Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 209356
Company: AMNEAL

Products on ANDA 209356

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 209356

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/02/2019	ORIG-1	Approval		STANDARD	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209356Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209356Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209356

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	212913	MYLAN
SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION;ORAL	Prescription	No	AB	213549	PD PARTNERS
SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION;ORAL	Prescription	No	AB	211884	VISTAPHARM