Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201865
Company: TARO

Products on ANDA 201865

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 201865

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2015	ORIG-1	Approval	Not Applicable			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