Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050694
Company: PAI HOLDINGS PHARM
Company: PAI HOLDINGS PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFOTAN IN PLASTIC CONTAINER | CEFOTETAN DISODIUM | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CEFOTAN IN PLASTIC CONTAINER | CEFOTETAN DISODIUM | EQ 20MG BASE/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 07/30/1993 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/50694.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/20/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/09/1995 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |