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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091625
Company: GRANULES

Products on ANDA 091625

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091625

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/2015	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
04/28/2021	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/01/2021	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/22/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091625

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	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	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	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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