Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021375
Company: FDN CONSUMER

Products on NDA 021375

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021375

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021375lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-375_Alvert_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-375_Alvert.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/19/2005	SUPPL-2	Manufacturing (CMC)-Formulation	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021375s002ltr.pdf

Labels for NDA 021375

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021375lbl.pdf

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

ALAVERT

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

TABLET, ORALLY DISINTEGRATING;ORAL; 10MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ALAVERT	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	No	021375	FDN CONSUMER
CLARITIN HIVES RELIEF REDITAB	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	Yes	020704	BAYER HEALTHCARE LLC
CLARITIN REDITABS	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	Yes	020704	BAYER HEALTHCARE LLC
LORATADINE	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	No	208477	AUROBINDO PHARMA LTD
LORATADINE	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	No	076011	PERRIGO PHARMA INTL
LORATADINE	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	No	214280	RUBICON
LORATADINE	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	No	213294	TENSHI
LORATADINE REDIDOSE	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	No	077153	SUN PHARM INDS LTD