Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NYSTATIN | NYSTATIN | 500,000 UNITS | TABLET;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
12/22/1988 | 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 |
---|---|---|---|---|---|
06/28/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/30/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/16/2000 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
05/16/2000 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/05/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/30/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
02/24/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/22/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/15/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
01/12/1994 | SUPPL-1 | 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 INC |
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 |
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