Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060764
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC | BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM | OINTMENT;OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 01/22/1981 | 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 |
|---|---|---|---|---|---|
| 02/01/2022 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/07/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/17/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
OINTMENT;OPHTHALMIC; 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC | BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM | OINTMENT;OPHTHALMIC | Prescription | No | AT | 064064 | BAUSCH AND LOMB |
| NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC | BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM | OINTMENT;OPHTHALMIC | Prescription | No | AT | 060764 | PADAGIS US |