Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070848
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUCRALFATE SUCRALFATE 1GM TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/29/1996 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/070848.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/27/2015 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

09/12/2008 SUPPL-31 Labeling

Label is not available on this site.

10/23/2007 SUPPL-27 Labeling

Label is not available on this site.

10/23/2002 SUPPL-18 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/23/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/2002 SUPPL-16 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/15/2002 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

11/13/2001 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

11/13/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/2001 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

05/29/2001 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/24/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

03/31/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/2000 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

03/26/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/18/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/08/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/08/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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 ALLERGAN
SUCRALFATE SUCRALFATE 1GM TABLET;ORAL Prescription No AB 074415 NOSTRUM LABS INC
SUCRALFATE SUCRALFATE 1GM TABLET;ORAL Prescription No AB 070848 TEVA

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