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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018333
Company: ABBVIE

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/30/1981 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2013 SUPPL-34 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
04/26/2007 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018333s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018333s032ltr.pdf
11/29/1995 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/15/1995 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/14/1994 SUPPL-27 Labeling

Label is not available on this site.
12/28/1992 SUPPL-26 Labeling

Label is not available on this site.
02/12/1991 SUPPL-25 Labeling

Label is not available on this site.
10/05/1990 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.
05/11/1990 SUPPL-23 Labeling

Label is not available on this site.
12/16/1988 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/05/1988 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/19/1988 SUPPL-17 Labeling

Label is not available on this site.
07/02/1986 SUPPL-14 Labeling

Label is not available on this site.
08/05/1987 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
09/24/1985 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/05/1987 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
05/11/1990 SUPPL-9 Efficacy-New Indication

Label is not available on this site.
05/14/1985 SUPPL-8 Labeling

Label is not available on this site.
09/24/1984 SUPPL-6 Labeling

Label is not available on this site.
04/22/1983 SUPPL-5 Labeling

Label is not available on this site.
06/01/1983 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/09/1983 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/16/1982 SUPPL-2 Labeling

Label is not available on this site.
03/09/1982 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/04/2013 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf
04/26/2007 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018333s032lbl.pdf

CARAFATE

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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