Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060700
Company: MEDIMETRIKS PHARMS
Company: MEDIMETRIKS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEO-SYNALAR | FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE | 0.025%;EQ 3.5MG BASE/GM | CREAM;TOPICAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 06/11/1963 | 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 |
|---|---|---|---|---|---|
| 02/25/2015 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1992 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 01/31/1991 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |