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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076805
Company: TARO

Products on ANDA 076805

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORATADINE	LORATADINE	1MG/ML	SYRUP;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076805

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/20/2004	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/21/2011	SUPPL-25	Labeling-Container/Carton Labels		Label is not available on this site.
08/19/2014	SUPPL-20	Labeling		Label is not available on this site.
08/19/2014	SUPPL-19	Labeling		Label is not available on this site.
08/31/2009	SUPPL-17	Labeling		Label is not available on this site.
03/03/2008	SUPPL-4	Labeling		Label is not available on this site.
09/19/2007	SUPPL-2	Labeling		Label is not available on this site.

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.

SYRUP;ORAL; 1MG/ML

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CLARITIN	LORATADINE	1MG/ML	SYRUP;ORAL	Over-the-counter	Yes	020641	BAYER HEALTHCARE LLC
LORATADINE	LORATADINE	1MG/ML	SYRUP;ORAL	Over-the-counter	No	208931	AUROBINDO PHARMA LTD
LORATADINE	LORATADINE	1MG/ML	SYRUP;ORAL	Over-the-counter	No	210409	HETERO LABS LTD III
LORATADINE	LORATADINE	1MG/ML	SYRUP;ORAL	Over-the-counter	No	077421	LANNETT CO INC
LORATADINE	LORATADINE	1MG/ML	SYRUP;ORAL	Over-the-counter	No	075728	PERRIGO
LORATADINE	LORATADINE	1MG/ML	SYRUP;ORAL	Over-the-counter	No	076805	TARO
LORATADINE	LORATADINE	1MG/ML	SYRUP;ORAL	Over-the-counter	No	201865	TARO
LORATADINE	LORATADINE	1MG/ML	SYRUP;ORAL	Over-the-counter	No	075815	WOCKHARDT BIO AG

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