Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071935
Company: AMNEAL PHARMS NY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription AB 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
10/13/1987 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
05/09/2016 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

12/26/2007 SUPPL-27 Labeling

Label is not available on this site.

08/07/2006 SUPPL-23 Labeling

Label is not available on this site.

07/03/2006 SUPPL-22 Labeling

Label is not available on this site.

09/25/2001 SUPPL-17 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

04/12/2000 SUPPL-16 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

04/12/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1999 SUPPL-14 Labeling

Label is not available on this site.

04/12/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

09/24/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/11/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/24/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

01/30/1992 SUPPL-7 Labeling

Label is not available on this site.

06/30/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/28/1988 SUPPL-3 Labeling

Label is not available on this site.

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

Label is not available on this site.

02/17/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

IBUPROFEN

TABLET;ORAL; 800MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 071935 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 078558 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 071268 CONTRACT PHARMACAL
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 072300 CONTRACT PHARMACAL
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 075682 DR REDDYS LA
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 076112 DR REDDYS LABS INC
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 091625 GRANULES INDIA LTD
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 090796 MARKSANS PHARMA
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 077114 PERRIGO R AND D
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 202413 SHANDONG XINHUA
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 078329 STRIDES PHARMA

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