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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075989
Company: PERRIGO PHARMA INTL

Products on ANDA 075989

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075989

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2004	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075989_original_approval_pkg.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2009	SUPPL-9	Labeling		Label is not available on this site.

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

LORATADINE AND PSEUDOEPHEDRINE SULFATE

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; 10MG;240MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CLARITIN-D 24 HOUR	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	Yes	020470	BAYER HEALTHCARE LLC
LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	075706	P AND L
LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	075989	PERRIGO PHARMA INTL
LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	076557	SUN PHARM INDS LTD

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