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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076154
Company: MYLAN

Products on ANDA 076154

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076154

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/20/2003	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76154.ta.pdf

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

LORATADINE

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

TABLET;ORAL; 10MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CLARITIN	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	Yes	019658	BAYER HEALTHCARE LLC
CLARITIN HIVES RELIEF	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	Yes	019658	BAYER HEALTHCARE LLC
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	076471	APOTEX INC
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	208314	AUROBINDO PHARMA LTD
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	210722	GRANULES
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	207569	GUARDIAN DRUG
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	211718	HETERO LABS LTD V
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	076154	MYLAN
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	076301	PERRIGO
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	075209	PLD ACQUISITIONS LLC
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	076134	SUN PHARM INDS LTD
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	214684	UNIQUE PHARM

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