Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078558
Company: AMNEAL PHARMS NY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription AB No No
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription AB No No
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
06/18/2007 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
07/22/2019 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/07/2011 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/26/2007 SUPPL-3 Labeling

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 PHARMS CO
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

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IBU-TAB IBUPROFEN 600MG TABLET;ORAL Prescription No AB 071059 ALRA
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 071335 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 078558 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 071268 CONTRACT PHARMACAL
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 075682 DR REDDYS LA
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 076112 DR REDDYS LABS INC
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 091625 GRANULES INDIA LTD
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 090796 MARKSANS PHARMA
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 077114 PERRIGO PHARMS CO
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 202413 SHANDONG XINHUA
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 078329 STRIDES PHARMA

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 PHARMS CO
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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