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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076518
Company: PERRIGO

Products on ANDA 076518

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076518

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76518ltrpdf.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/07/2011	SUPPL-30	Labeling		Label is not available on this site.
02/07/2011	SUPPL-25	Labeling		Label is not available on this site.
09/23/2008	SUPPL-24	Labeling		Label is not available on this site.
12/19/2006	SUPPL-16	Labeling		Label is not available on this site.
03/22/2006	SUPPL-15	Labeling		Label is not available on this site.

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

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

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; 220MG;120MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	077381	DR REDDYS LABS INC
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	076518	PERRIGO

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