Drugs@FDA: FDA Approved Drug Products

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

Label is not available on this site.

02/21/2019 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

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.

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 PFIZER
ADVIL MIGRAINE LIQUI-GELS IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter Yes 020402 PFIZER
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 INC
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 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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