Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071333
Company: AMNEAL PHARMS NY
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
02/17/1987 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
05/08/2011 SUPPL-45 Labeling-Package Insert

Label is not available on this site.

04/25/2012 SUPPL-44 Labeling

Label is not available on this site.

08/21/2008 SUPPL-39 Labeling

Label is not available on this site.

05/09/2006 SUPPL-33 Labeling

Label is not available on this site.

11/16/2005 SUPPL-32 Labeling

Label is not available on this site.

10/22/2002 SUPPL-26 Labeling

Label is not available on this site.

09/25/2001 SUPPL-25 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/13/2001 SUPPL-24 Labeling

Label is not available on this site.

12/04/2000 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

04/12/2000 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/2000 SUPPL-21 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

09/13/1999 SUPPL-20 Labeling

Label is not available on this site.

04/12/2000 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

09/24/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/11/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/25/2000 SUPPL-15 Labeling

Label is not available on this site.

07/25/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/25/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/25/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/24/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/22/1994 SUPPL-9 Labeling

Label is not available on this site.

01/20/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/26/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/05/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/05/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/05/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/08/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/17/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/24/1987 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
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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