Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NYSTATIN | NYSTATIN | 500,000 UNITS | TABLET;ORAL | Prescription | AA | No | 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 |
---|---|---|---|---|---|---|---|
01/16/1984 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/30/2001 | SUPPL-39 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
07/07/2000 | SUPPL-38 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/21/1999 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/09/1998 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/19/1997 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/05/1997 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/02/1997 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
11/26/1996 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/04/1996 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/07/1997 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/16/1996 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/25/1996 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/25/1996 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/25/1996 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/10/1995 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/02/1995 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/09/1994 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
01/14/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/14/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/14/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/14/1994 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/14/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/14/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/03/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/03/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
12/03/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/31/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/31/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/01/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/01/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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04/01/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/03/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
NYSTATIN
TABLET;ORAL; 500,000 UNITS
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NYSTATIN | NYSTATIN | 500,000 UNITS | TABLET;ORAL | Prescription | No | AA | 062474 | HERITAGE PHARMS |
NYSTATIN | NYSTATIN | 500,000 UNITS | TABLET;ORAL | Prescription | No | AA | 062838 | SUN PHARM INDUSTRIES |
NYSTATIN | NYSTATIN | 500,000 UNITS | TABLET;ORAL | Prescription | No | AA | 062506 | TEVA |