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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208687
Company: ALKEM LABS LTD

Products on ANDA 208687

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZATHIOPRINE	AZATHIOPRINE	25MG	TABLET;ORAL	Prescription	AB	No	No
AZATHIOPRINE	AZATHIOPRINE	50MG	TABLET;ORAL	Prescription	AB	No	No
AZATHIOPRINE	AZATHIOPRINE	75MG	TABLET;ORAL	Prescription	AB	No	No
AZATHIOPRINE	AZATHIOPRINE	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208687

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/27/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/13/2025	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208687

AZATHIOPRINE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZASAN	AZATHIOPRINE	25MG	TABLET;ORAL	Prescription	No	AB	075252	AAIPHARMA LLC
AZATHIOPRINE	AZATHIOPRINE	25MG	TABLET;ORAL	Prescription	No	AB	208687	ALKEM LABS LTD
AZATHIOPRINE	AZATHIOPRINE	25MG	TABLET;ORAL	Prescription	No	AB	077621	ZYDUS PHARMS USA

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZASAN	AZATHIOPRINE	50MG	TABLET;ORAL	Prescription	No	AB	075252	AAIPHARMA LLC
AZATHIOPRINE	AZATHIOPRINE	50MG	TABLET;ORAL	Prescription	No	AB	208687	ALKEM LABS LTD
AZATHIOPRINE	AZATHIOPRINE	50MG	TABLET;ORAL	Prescription	No	AB	074069	AMNEAL
AZATHIOPRINE	AZATHIOPRINE	50MG	TABLET;ORAL	Prescription	No	AB	075568	RISING
AZATHIOPRINE	AZATHIOPRINE	50MG	TABLET;ORAL	Prescription	No	AB	077621	ZYDUS PHARMS USA
IMURAN	AZATHIOPRINE	50MG	TABLET;ORAL	Prescription	Yes	AB	016324	LEGACY PHARMA

TABLET;ORAL; 75MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZASAN	AZATHIOPRINE	75MG	TABLET;ORAL	Prescription	No	AB	075252	AAIPHARMA LLC
AZATHIOPRINE	AZATHIOPRINE	75MG	TABLET;ORAL	Prescription	No	AB	208687	ALKEM LABS LTD
AZATHIOPRINE	AZATHIOPRINE	75MG	TABLET;ORAL	Prescription	No	AB	074069	AMNEAL
AZATHIOPRINE	AZATHIOPRINE	75MG	TABLET;ORAL	Prescription	No	AB	077621	ZYDUS PHARMS USA

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZASAN	AZATHIOPRINE	100MG	TABLET;ORAL	Prescription	No	AB	075252	AAIPHARMA LLC
AZATHIOPRINE	AZATHIOPRINE	100MG	TABLET;ORAL	Prescription	No	AB	208687	ALKEM LABS LTD
AZATHIOPRINE	AZATHIOPRINE	100MG	TABLET;ORAL	Prescription	No	AB	074069	AMNEAL
AZATHIOPRINE	AZATHIOPRINE	100MG	TABLET;ORAL	Prescription	No	AB	077621	ZYDUS PHARMS USA

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