Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071163
Company: OHM
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
07/15/1986 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
06/15/2010 SUPPL-54 Labeling-Container/Carton Labels

Label is not available on this site.

08/22/2008 SUPPL-53 Labeling

Label is not available on this site.

10/02/2006 SUPPL-52 Labeling

Label is not available on this site.

03/22/2006 SUPPL-48 Labeling

Label is not available on this site.

08/16/2001 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/2001 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

09/18/2000 SUPPL-37 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/08/1999 SUPPL-35 Labeling

Label is not available on this site.

11/18/1998 SUPPL-34 Labeling

Label is not available on this site.

10/06/1997 SUPPL-32 Labeling

Label is not available on this site.

08/05/1994 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

07/29/1993 SUPPL-30 Labeling

Label is not available on this site.

11/02/1992 SUPPL-29 Labeling

Label is not available on this site.

09/21/1992 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/21/1992 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/21/1993 SUPPL-26 Labeling

Label is not available on this site.

04/21/1993 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/02/1990 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/22/1989 SUPPL-21 Labeling

Label is not available on this site.

04/17/1990 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/18/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/21/1991 SUPPL-16 Labeling

Label is not available on this site.

11/21/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/21/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/31/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/31/1989 SUPPL-12 Labeling

Label is not available on this site.

06/03/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/28/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/28/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/09/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/10/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/03/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/03/1986 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 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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