Drugs@FDA: FDA-Approved Drugs
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 | 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 |