Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075995
Company: PERRIGO
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
03/14/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75995AP.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/02/2004 SUPPL-1 Labeling

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 No 018989 PFIZER
IBU-TAB 200 IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071057 ALRA
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 LTD
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 079174 GRANULES INDIA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 202312 GRANULES INDIA LTD
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 070985 MERRO PHARM
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071163 OHM
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 070481 PAR PHARM
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 072096 PERRIGO
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 075995 PERRIGO
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 077349 PERRIGO R AND D
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 206990 SHANDONG XINHUA
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
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
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071639 VINTAGE PHARMS
IBUPROHM IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071214 OHM LABS
MOTRIN IB IBUPROFEN 200MG TABLET;ORAL Over-the-counter Yes 019012 J AND J CONSUMER INC
TAB-PROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 072095 PERRIGO

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