Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074415
Company: NOSTRUM LABS INC

Products on ANDA 074415

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 074415

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/08/1998	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74415ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74415ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2015	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
01/16/2008	SUPPL-8	Labeling		Label is not available on this site.
09/19/2007	SUPPL-6	Labeling		Label is not available on this site.
02/02/2000	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
02/02/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 074415

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