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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214699
Company: ALKEM LABS LTD
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
09/13/2021 ORIG-1 Approval STANDARD

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
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 214699 ALKEM LABS LTD
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 213794 AUROBINDO PHARMA LTD
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
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 077114 L PERRIGO CO
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 090796 MARKSANS PHARMA
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 215318 YICHANG HUMANWELL

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 214699 ALKEM LABS LTD
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 213794 AUROBINDO PHARMA LTD
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
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 077114 L PERRIGO CO
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 090796 MARKSANS PHARMA
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 202413 SHANDONG XINHUA
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 078329 STRIDES PHARMA
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 215318 YICHANG HUMANWELL

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 214699 ALKEM LABS LTD
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 213794 AUROBINDO PHARMA LTD
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
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 077114 L PERRIGO CO
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 090796 MARKSANS PHARMA
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 202413 SHANDONG XINHUA
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 078329 STRIDES PHARMA
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 215318 YICHANG HUMANWELL
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