Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209114
Company: COSETTE
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
10/06/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/23/2019 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
NYSTATIN
OINTMENT;TOPICAL; 100,000 UNITS/GM
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT;TOPICAL | Prescription | No | AT | 062840 | ACTAVIS MID ATLANTIC |
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT;TOPICAL | Prescription | No | AT | 209114 | COSETTE |
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT;TOPICAL | Prescription | No | AT | 062124 | FOUGERA PHARMS |
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT;TOPICAL | Prescription | No | AT | 209082 | LYNE |
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT;TOPICAL | Prescription | No | AT | 213826 | MACLEODS PHARMS LTD |
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT;TOPICAL | Prescription | No | AT | 062472 | PADAGIS US |
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT;TOPICAL | Prescription | No | AT | 207767 | ZYDUS LIFESCIENCES |