Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216204
Company: AUROBINDO PHARMA

Products on ANDA 216204

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN AND DIPHENHYDRAMINE CITRATE	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216204

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

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

IBUPROFEN AND DIPHENHYDRAMINE CITRATE

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

TABLET;ORAL; 38MG;200MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ADVIL PM	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET;ORAL	Over-the-counter	Yes	021394	HALEON US HOLDINGS
IBUPROFEN AND DIPHENHYDRAMINE CITRATE	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET;ORAL	Over-the-counter	No	216204	AUROBINDO PHARMA
IBUPROFEN AND DIPHENHYDRAMINE CITRATE	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET;ORAL	Over-the-counter	No	090619	DR REDDYS LABS LTD
IBUPROFEN AND DIPHENHYDRAMINE CITRATE	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET;ORAL	Over-the-counter	No	079113	PERRIGO R AND D
IBUPROFEN AND DIPHENHYDRAMINE CITRATE	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET;ORAL	Over-the-counter	No	211404	PLD ACQUISITIONS LLC