Drugs@FDA: FDA-Approved Drugs
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROTAMINE SULFATE | PROTAMINE SULFATE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/13/1969 | 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 |
|---|---|---|---|---|---|
| 04/22/1998 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/08/1997 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/19/1996 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1996 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/1994 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 08/18/1993 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 01/08/1991 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 03/05/1990 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/13/1989 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 01/07/1988 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 02/18/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1986 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/24/1985 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/25/1983 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1982 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/17/1985 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/21/1982 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/16/1981 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1979 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/21/1976 | SUPPL-8 | Labeling |
Label is not available on this site. |