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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075153
Company: L PERRIGO CO

Products on ANDA 075153

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075153

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75153ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2011	SUPPL-34	Labeling-Container/Carton Labels		Label is not available on this site.
04/20/2005	SUPPL-17	Labeling		Label is not available on this site.
12/09/2002	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
12/12/2001	SUPPL-8	Labeling		Label is not available on this site.
10/22/2001	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
05/07/2002	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/07/2002	SUPPL-5	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
04/17/2001	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
04/17/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
02/28/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

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

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; 120MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	209008	AUROBINDO PHARMA
PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	075153	L PERRIGO CO
PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	077442	SUN PHARM INDS LTD

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