Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064118
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NYSTOP | NYSTATIN | 100,000 UNITS/GM | POWDER;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 |
|---|---|---|---|---|---|---|---|
| 08/16/1996 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/064118.PDF |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/13/2002 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 11/13/2002 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/08/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/21/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/10/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
NYSTOP
POWDER;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 | POWDER;TOPICAL | Prescription | No | AT | 065175 | ADRASTEA PHARMA |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | POWDER;TOPICAL | Prescription | No | AT | 065203 | DR REDDYS LABS SA |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | POWDER;TOPICAL | Prescription | No | AT | 210532 | EPIC PHARMA LLC |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | POWDER;TOPICAL | Prescription | No | AT | 065138 | LUPIN |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | POWDER;TOPICAL | Prescription | No | AT | 208838 | LYNE |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | POWDER;TOPICAL | Prescription | No | AT | 065183 | UPSHER SMITH LABS |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | POWDER;TOPICAL | Prescription | No | AT | 208581 | ZYDUS PHARMS |
| NYSTOP | NYSTATIN | 100,000 UNITS/GM | POWDER;TOPICAL | Prescription | No | AT | 064118 | PADAGIS US |