Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050613
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFOBID IN PLASTIC CONTAINER | CEFOPERAZONE SODIUM | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CEFOBID IN PLASTIC CONTAINER | CEFOPERAZONE SODIUM | 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 |
|---|---|---|---|---|---|---|---|
| 07/23/1986 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/01/1998 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/28/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/03/1996 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/01/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1987 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/20/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/29/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |