Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060286
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PFIZERPEN-AS | PENICILLIN G PROCAINE | 300,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| PFIZERPEN-AS | PENICILLIN G PROCAINE | 600,000 UNITS/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 |
|---|---|---|---|---|---|---|---|
| 11/01/1950 | 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 |
|---|---|---|---|---|---|
| 07/27/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |