Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065203
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | POWDER;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
07/15/2004 | 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 |
---|---|---|---|---|---|
02/13/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
NYSTATIN
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 |