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): 076117
Company: DR REDDYS LABS INC

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
11/20/2001 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76117ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/076117.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/18/2015 SUPPL-5 Labeling

Label is not available on this site.
10/01/2002 SUPPL-1 Manufacturing (CMC)-Packaging

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 079233 AMNEAL PHARMS
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071333 AMNEAL PHARMS NY
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 072299 CONTRACT PHARMACAL
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 075661 DR REDDYS LA
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 070481 STRIDES PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 079129 STRIDES PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 091355 STRIDES PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 206989 STRIDES PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 207052 STRIDES PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071229 VINTAGE PHARMS
MOTRIN IB IBUPROFEN 200MG TABLET;ORAL Over-the-counter Yes 019012 J AND J CONSUMER INC
Back to Top