U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 072299
Company: ADAPTIS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 200MG TABLET;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
07/01/1988 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/31/2006 SUPPL-14 Labeling

Label is not available on this site.
09/29/2004 SUPPL-12 Labeling

Label is not available on this site.
12/01/1999 SUPPL-10 Labeling

Label is not available on this site.
07/23/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
07/24/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
06/28/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
08/24/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
12/12/1989 SUPPL-4 Bioequivalence

Label is not available on this site.
09/23/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
09/23/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
09/23/1991 SUPPL-1 Manufacturing (CMC)

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.

TABLET;ORAL; 200MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL IBUPROFEN 200MG TABLET;ORAL Over-the-counter Yes 018989 HALEON US HOLDINGS
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 072299 ADAPTIS
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 072199 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 208865 AUROBINDO PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 076460 AVEMA PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 075661 DR REDDYS
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 076117 DR REDDYS LABS INC
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 202312 GRANULES
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 079174 GRANULES INDIA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 075010 LNK
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 075139 LNK
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 091237 MARKSANS PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 091239 MARKSANS PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 073019 MCNEIL
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 072096 PERRIGO
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 077349 PERRIGO R AND D
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 207095 SHANDONG XINHUA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 079129 STRIDES PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 091355 STRIDES PHARMA
MOTRIN IB IBUPROFEN 200MG TABLET;ORAL Over-the-counter Yes 019012 KENVUE BRANDS
Back to Top