Drugs@FDA: FDA-Approved Drugs
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MANDOL | CEFAMANDOLE NAFATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MANDOL | CEFAMANDOLE NAFATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MANDOL | CEFAMANDOLE NAFATE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MANDOL | CEFAMANDOLE NAFATE | EQ 10GM BASE/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 09/27/1978 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/22/2002 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 03/04/2003 | SUPPL-62 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50504slr062ltr.pdf |
| 01/05/1999 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/1996 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/2002 | SUPPL-59 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50504s059ltr.pdf |
| 03/23/1993 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1992 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 11/16/1981 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 09/04/1981 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 02/11/1981 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/23/1980 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 11/20/1980 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 11/20/1980 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 11/20/1980 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 11/20/1980 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 10/28/1980 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 10/03/1980 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 07/01/1980 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 06/17/1980 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 05/28/1980 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 05/01/1980 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 05/01/1980 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/14/1980 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 11/13/1979 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 09/10/1979 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/01/1979 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 05/15/1979 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 08/01/1979 | SUPPL-35 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/21/1979 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 02/06/1979 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 01/15/1979 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 11/21/1978 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 11/15/1978 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/14/1992 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 06/18/1993 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 06/13/1991 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 09/03/1982 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 05/10/1995 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/29/1982 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 03/12/1986 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 03/12/1986 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/15/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 09/07/1984 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/06/1983 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/24/1983 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/05/1983 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/21/1983 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/20/1983 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/19/1981 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/1983 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/18/1983 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/17/1983 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/1983 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1982 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/18/1982 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/17/1982 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |