Sameness Evaluations in an ANDA — Active Ingredients | FDA Skip to main content Skip to FDA

Tainted Honey-based Products with Hidden Active Drug Ingredients | FDA Skip to main content Skip to FDA

FDA Announces Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Drug Products

Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry | FDA Skip to main

Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers Guidance for Industry

FDA Update on Post-market Assessment of Certain Food Ingredients | FDA Skip to main content Skip to

stores. FDA laboratory analysis confirmed that ENDUREA contains tadalafil and sildenafil, the active ingredients in the

FDA laboratory analysis confirmed that Meta Forte contains tadalafil and sildenafil, the active ingredients in the

FDA laboratory analysis confirmed that Infinity 10K contains tadalafil and sildenafil, the active ingredients in the

CPG Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to

analysis confirmed that Natural MiracleZEN GOLD 60000 contains sildenafil and tadalafil, the active ingredients in the

laboratory analysis confirmed that Mega 9K 800000 contains tadalafil and sildenafil, the active ingredients in the

muscle and arthritic pain. FDA laboratory analysis confirmed that Pro ArthMax contains the active ingredients diclofenac, ibuprofen, naproxen

Public Notification: Jianbu Huqian Wan contains hidden drug ingredients | FDA Skip to main content Skip to FDA

Submitted 75-Day Premarket Notifications for New Dietary Ingredients | FDA Skip to main content Skip to

stores. FDA laboratory analysis confirmed that Sustain® contains tadalafil and avanafil, the active ingredients in the

Dr. Ergin’s SugarMD Advanced Glucose Support contains glyburide and metformin, the active ingredients in several

policy on the use of alternate sources of the active pharmaceutical ingredients (API) in

section for generic Type A medicated articles (TAMAs) containing poorly soluble, locally acting, active pharmaceutical ingredients (APIs) that

are filed but not active because deficiencies were identified during the FDA’s review. Ingredients that are Generally Recognized

Exclusive For Men & Women contains tadalafil and sildenafil, the active ingredients in the

VIP Royal Honey for Him contains sildenafil and tadalafil, the active ingredients in the

This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in

FDA is Using Innovative Methods to Prevent Illegal Products with Hidden Drug Ingredients from Entering the United

the product name. Testing showed that some of these products were contaminated with active prescription drug ingredients not

NORF 20 contains hidden drug ingredients | FDA Skip to main content Skip to FDA Search Skip to

Public Notification: Detox Plus contains hidden drug ingredients | FDA Skip to main content Skip to FDA Search

Public Notification: Fruta Bio contains hidden drug ingredients | FDA Skip to main content Skip to FDA Search

Public Notification: Genesis Ultra Slim Gold contains hidden drug ingredients | FDA Skip to main content Skip to FDA

Public Notification: Lipopastilla + Gold Max contains hidden drug ingredients | FDA Skip to main content Skip to FDA

metric and apothecary systems to declare the quantity of active ingredients present in

Procedures for OTC Drug Products found on this page: Drug Review Procedures Category II Active Ingredients Administrative Record Miscellaneous

listed on the product label. Sildenafil and tadalafil are the active ingredients in the

analysis confirmed that Special Edition Platinum 10K contains tadalafil and vardenafil, the active ingredients in the

listed on the product label. Sildenafil and tadalafil are the active ingredients in the

or bupropion not listed on the product label. Fluoxetine and bupropion are active ingredients in FDA

not listed on the product label. Although dexamethasone, diclofenac, and methocarbamol are active ingredients in FDA

HimGo may be harmful due to hidden drug ingredients | FDA Skip to main content Skip to

PeakMax may be harmful due to hidden drug ingredients | FDA Skip to main content Skip to

LipoFit Turbo may be harmful due to hidden drug ingredients | FDA Skip to main content Skip to

FATZorb may be harmful due to hidden drug ingredients | FDA Skip to main content Skip to

Approved Active Moieties That Have Appeared On The National Institutes Of Health’s (NIH

listed on the product label.  Tadalafil and sildenafil are the active ingredients in the

listed on the product label. Sildenafil and tadalafil are the active ingredients in the

listed on the product label. Sildenafil and tadalafil are the active ingredients in the

listed on the product label. Tadalafil and sildenafil are the active ingredients in the

Fouzee SugarLin Herbal Formula may be harmful due to hidden drug ingredients | FDA Skip to main content

HON-E-LING may be harmful due to hidden drug ingredients | FDA Skip to main content Skip

Public Notification: Body Shape Weight Loss System contains hidden drug ingredients | FDA Skip to main content Skip to

listed on the product label. Sildenafil and tadalafil are the active ingredients in the

listed on the product label. Sildenafil and tadalafil are the active ingredients in the

Food and Drug Administration (FDA) has issued a final rule determining that certain active ingredients in over

Over-the-Counter Human Use   OTC Antiemetic Drug Products found on this page: Original Active Ingredients and Labeling

Industry Health Professionals Federal, State and Local Officials In this section : Cosmetic Ingredients Cosmetic Ingredients Allergens in

Over-the-Counter Human Use     OTC Antihistamine Drug Products found on this page: Original Active Ingredients and Labeling

is for illustrative purposes only. What It Means Click to learn more: Active Ingredient(s) Active Ingredient

Over-the-Counter Human Use OTC Anticaries Drug Products found on this page: Original Active Ingredients and Labeling

Over-the-Counter Human Use OTC Acne Drug Products found on this page: Original Active Ingredients & Labeling Benzoyl

Over-the-Counter Human Use  OTC External Analgesic Drug Products found on this page: Original Active Ingredients and Labeling

Over-the-Counter Human Use   OTC Antidiarrheal Drug Products found on this page: Original Active Ingredients and Labeling

Over-the-Counter Human Use   OTC Antitussive Drug Products found on this page: Original Active Ingredients and Labeling

Use: First Aid Antibiotic Drug Products OTC Topical Antibiotic Drug Products found on this page: Original Active Ingredients and Labeling

Over-the-Counter Human Use   OTC Bronchodilator Drug Products found on this page: Original Active Ingredients and Labeling

Over-the-Counter Human Use   OTC Anorectal Drug Products found on this page: Original Active Ingredients & Labeling Sodium

Over-the-Counter Human Use OTC Internal Analgesic Drug Products found on this page: Original Active Ingredients and Labeling

Food and Drug Administration (FDA) issued a final rule determining that certain active ingredients in over

final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer

Antiseptic Products is part of FDA’s larger, ongoing review of antiseptic active ingredients to determine

series of actions on the FDA’s review of OTC antiseptic active ingredients Share Post Linkedin

asked manufacturers of hand sanitizers for more information on three commonly used active ingredients in OTC

Historical Status of OTC Rulemakings Final Monograph ( 21 CFR 310.533 ): Drug Products Containing Active Ingredients Offered Over-the

been revised to reflect the sum of the two active ingredients. Thus, one vial

Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered to

ingredients and inactive ingredients. In the case of sunscreen, active ingredients are the

and carton labels displaying the individual strengths of the two active ingredients (i.e., 2 gram

the review of safety and effectiveness of nonprescription sunscreen active ingredients. The SIA

Over-the-Counter Human Use   OTC Antacid Drug Products found on this page: Original Active Ingredients and Labeling

unapproved drugs and repackaged and relabeled drugs. Unfinished drugs Drug establishments producing active pharmaceutical ingredients are required

Industry Health Professionals Federal, State and Local Officials In this section : Food Ingredients & Packaging Human Food

discuss the safety and effectiveness data gaps for the active ingredients benzethonium and

Over-the-Counter Human Use OTC Nasal Decongestant Drug Products found on this page: Original Active Ingredients and Labeling

of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section

5%, and epinephrine 1% as active ingredients. Neither epinephrine nor prilocaine are permitted as active ingredients by M017. Moreover

air after the stopper had been punctured multiple times. Use of expired active pharmaceutical ingredients to

frequently misrepresented as dietary supplements and that contain hidden and potentially harmful active drug ingredients. Distributing unapproved

drug products marketed without an approved application and/or include combinations of active ingredients that do not

a drug product that is labeled as ‘homeopathic,’ and is labeled as containing only active ingredients and dilutions

review, a product’s formulation, including the concentration of its active ingredients, its labeling, indications

among the conditions addressed will be the permissibility of including certain active ingredients in sunscreen

Code of Federal Regulations Title 21 21 CFR Part 300 OTC Drug Monograph Rulemakings OTC Active Ingredients - Alphabetical Listing OTC

taking an OTC medicine. Here's what to look for: PRODUCT NAME "ACTIVE INGREDIENTS":  therapeutic substances in

are phosphodiesterase type-5 (PDE-5) inhibitors. Tadalafil and sildenafil are the active ingredients in the

for treating pain and fever, is one of the most common active ingredients in the

drug products marketed without an approved application and/or include combinations of active ingredients that do not

provide the marketing conditions for some OTC drug products including the active ingredients, labeling, and

drug products marketed without an approved application and/or include combinations of active ingredients that do not