Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020755
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAVERJECT | ALPROSTADIL | 0.005MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CAVERJECT | ALPROSTADIL | 0.01MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CAVERJECT | ALPROSTADIL | 0.02MG/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 |
|---|---|---|---|---|---|---|---|
| 10/31/1997 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020755_caverject_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/02/2003 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20379slr017,20755slr005,21212slr002ltr.pdf |
| 12/20/2001 | SUPPL-4 | Labeling |
Label is not available on this site. |