Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212795
Company: INSTAPILL

Products on ANDA 212795

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORATADINE	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212795

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212795Orig1s000ltr.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.

TABLET, ORALLY DISINTEGRATING;ORAL; 5MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CLARITIN REDITABS	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	Yes	021993	BAYER HEALTHCARE LLC
LORATADINE	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	No	212795	INSTAPILL