Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021734
Company: TARO

Products on NDA 021734

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORATADINE	LORATADINE	1MG/ML	SUSPENSION;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021734

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/04/2005	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021734lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021734ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021734s000TOC.cfm

Labels for NDA 021734

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/04/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021734lbl.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.

SUSPENSION;ORAL; 1MG/ML

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
LORATADINE	LORATADINE	1MG/ML	SUSPENSION;ORAL	Over-the-counter	Yes	021734	TARO