Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062822
Company: MONARCH PHARMS
Company: MONARCH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEDIOTIC | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OTIC | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 09/29/1987 | 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 |
|---|---|---|---|---|---|
| 08/10/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/23/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/08/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/03/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |