Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075682
Company: DR REDDYS LA
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/14/2001 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75682ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075682.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2016 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

02/26/2015 SUPPL-8 Labeling

Label is not available on this site.

03/16/2015 SUPPL-4 Labeling

Label is not available on this site.

02/17/2006 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 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

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 R AND D
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 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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