Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 005521
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 20,000 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 |
|---|---|---|---|---|---|---|---|
| 05/19/1944 | 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 |
|---|---|---|---|---|---|
| 05/23/2000 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/1998 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/1996 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1989 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 10/27/1989 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/27/1999 | SUPPL-19 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/01/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/01/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 05/13/1985 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/16/1981 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1981 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/07/1979 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/17/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/08/1982 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1976 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |