Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062474
Company: HERITAGE PHARMS
Company: HERITAGE PHARMS
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 |
---|---|---|---|---|---|---|---|
12/22/1983 | 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 |
---|---|---|---|---|---|
11/01/2012 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
07/11/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
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12/15/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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12/15/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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10/29/1997 | SUPPL-6 | 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 |