Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065088
Company: SAPTALIS PHARMS
Company: SAPTALIS PHARMS
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 02/06/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65010ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/10/2017 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |