Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215486
Company: MARKSANS PHARMA

Products on ANDA 215486

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215486

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

ACETAMINOPHEN

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, EXTENDED RELEASE;ORAL; 650MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	207229	AUROBINDO PHARMA
ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	211544	GRANULES
ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	215486	MARKSANS PHARMA
ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	076200	OHM LABS
ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	075077	PERRIGO
TYLENOL	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	Yes	019872	KENVUE BRANDS