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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202538
Company: BIONPHARMA

Products on ANDA 202538

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202538

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/2018	ORIG-1	Approval				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.

CAPSULE;ORAL; 10MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CLARITIN	LORATADINE	10MG	CAPSULE;ORAL	Over-the-counter	Yes	021952	BAYER HEALTHCARE LLC
LORATADINE	LORATADINE	10MG	CAPSULE;ORAL	Over-the-counter	No	202538	BIONPHARMA
LORATADINE	LORATADINE	10MG	CAPSULE;ORAL	Over-the-counter	No	206214	MARKSANS PHARMA

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