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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215705
Company: ZYDUS LIFESCIENCES

Products on ANDA 215705

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUCRALFATE	SUCRALFATE	1GM	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215705

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/03/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215705

SUCRALFATE

TABLET;ORAL; 1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARAFATE	SUCRALFATE	1GM	TABLET;ORAL	Prescription	Yes	AB	018333	ABBVIE
SUCRALFATE	SUCRALFATE	1GM	TABLET;ORAL	Prescription	No	AB	215576	AMNEAL PHARMS
SUCRALFATE	SUCRALFATE	1GM	TABLET;ORAL	Prescription	No	AB	074415	NOSTRUM LABS INC
SUCRALFATE	SUCRALFATE	1GM	TABLET;ORAL	Prescription	No	AB	070848	TEVA
SUCRALFATE	SUCRALFATE	1GM	TABLET;ORAL	Prescription	No	AB	215705	ZYDUS LIFESCIENCES

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