Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077421
Company: LANNETT CO INC

Products on ANDA 077421

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 077421

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077421s000LTR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/07/2014	SUPPL-8	Labeling-Container/Carton Labels		Label is not available on this site.
08/12/2014	SUPPL-4	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