Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212913
Company: MYLAN

Products on ANDA 212913

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212913

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212913

SUCRALFATE

SUSPENSION;ORAL; 1GM/10ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARAFATE	SUCRALFATE	1GM/10ML	SUSPENSION;ORAL	Prescription	Yes	AB	019183	ABBVIE
SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION;ORAL	Prescription	No	AB	216726	ABON PHARMS LLC
SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION;ORAL	Prescription	No	AB	209356	AMNEAL
SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION;ORAL	Prescription	No	AB	217126	COSETTE
SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION;ORAL	Prescription	No	AB	212141	GLENMARK PHARMS LTD
SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION;ORAL	Prescription	No	AB	212913	MYLAN
SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION;ORAL	Prescription	No	AB	211780	PADAGIS US
SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION;ORAL	Prescription	No	AB	213549	PD PARTNERS
SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION;ORAL	Prescription	No	AB	216474	STRIDES PHARMA
SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION;ORAL	Prescription	No	AB	211884	VISTAPHARM LLC