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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078682
Company: BIONPHARMA

Other Important Information from FDA

Products on ANDA 078682

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078682

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/24/2009	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/078682.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2019	SUPPL-21	Labeling-Container/Carton Labels, Labeling-Package Insert	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/078682Orig1s016s021.pdf
11/12/2019	SUPPL-20	Manufacturing (CMC)-Formulation	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/078682Orig1s020.pdf
02/21/2019	SUPPL-16	Labeling-Package Insert	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/078682Orig1s016s021.pdf
07/31/2013	SUPPL-12	Labeling-Proprietary Name Change, Labeling-Container/Carton Labels		Label is not available on this site.
04/27/2012	SUPPL-7	Labeling		Label is not available on this site.
03/12/2013	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.

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

IBUPROFEN

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

CAPSULE;ORAL; EQ 200MG FREE ACID AND POTASSIUM SALT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ADVIL LIQUI-GELS	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	Yes	020402	HALEON US HOLDINGS
ADVIL MIGRAINE LIQUI-GELS	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	Yes	020402	HALEON US HOLDINGS
IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	No	202300	AMNEAL PHARMS
IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	No	206999	ASCENT PHARMS INC
IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	No	207753	AUROBINDO PHARMA LTD
IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	No	078682	BIONPHARMA
IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	No	206568	HUMANWELL PURACAP
IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	No	079205	MARKSANS PHARMA
IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	No	077338	P AND L DEV LLC
IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	No	217236	PATHEON SOFTGELS
IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	No	203599	SOFGEN PHARMS
IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	No	204469	STRIDES PHARMA

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