Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009238
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROGESTERONE | PROGESTERONE | 50MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| PROGESTERONE | PROGESTERONE | 25MG/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 |
|---|---|---|---|---|---|---|---|
| 11/01/1974 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 11/16/1984 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/09/1981 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-11 | Efficacy |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-8 | Efficacy |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |