An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019183
Company: ABBVIE

Products on NDA 019183

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARAFATE	SUCRALFATE	1GM/10ML	SUSPENSION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019183

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/1993	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019183_biopharm.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2023	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019183Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019183Orig1s021ltr.pdf
08/15/2017	SUPPL-19	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019183s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019183Orig1s019ltr.pdf
06/06/2016	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/04/2013	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018333Orig1s034,019183Orig1s016ltr.pdf
12/21/2010	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019183s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019183s014ltr.pdf
04/26/2007	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019183s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019183s011ltr.pdf
02/10/2006	SUPPL-9	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019183s009ltr.pdf
02/08/2000	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
07/16/1997	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
08/14/1997	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/21/1995	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/13/1994	SUPPL-2	Labeling		Label is not available on this site.
04/11/1994	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019183

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2023	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019183Orig1s021lbl.pdf
08/15/2017	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019183s019lbl.pdf
08/15/2017	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019183s019lbl.pdf
03/04/2013	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf
12/21/2010	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019183s014lbl.pdf
04/26/2007	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019183s011lbl.pdf

Therapeutic Equivalents for NDA 019183

CARAFATE

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

Top