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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077153
Company: SUN PHARM INDS LTD

Products on ANDA 077153

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077153

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/11/2007	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
03/03/2020	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/26/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

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

LORATADINE REDIDOSE

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	213294	INSTAPILL
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 RESEARCH
LORATADINE REDIDOSE	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	No	077153	SUN PHARM INDS LTD

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