Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206214
Company: MARKSANS PHARMA

Products on ANDA 206214

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 206214

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/2016	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206214Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206214Orig1s000ltr.pdf

Labels for ANDA 206214

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206214Orig1s000lbl.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.

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