Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071644
Company: VINTAGE PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 400MG 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
02/01/1988 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-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/18/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
10/18/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
10/18/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
09/19/1989 SUPPL-5 Bioequivalence

Label is not available on this site.
06/12/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
06/17/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
06/17/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

IBUPROFEN

TABLET;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IBU-TAB IBUPROFEN 400MG TABLET;ORAL Prescription No AB 071058 ALRA
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 071334 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 078558 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 071267 CONTRACT PHARMACAL
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 071268 CONTRACT PHARMACAL
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 075682 DR REDDYS LA
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 076112 DR REDDYS LABS INC
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 091625 GRANULES INDIA LTD
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 090796 MARKSANS PHARMA
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 077114 PERRIGO R AND D
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 202413 SHANDONG XINHUA
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 078329 STRIDES PHARMA
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 071644 VINTAGE PHARMS

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