Drugs@FDA: FDA-Approved Drugs
Company: DEPROCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SCANDONEST PLAIN | MEPIVACAINE HYDROCHLORIDE | 3% | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/10/1984 | 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 |
---|---|---|---|---|---|
11/02/2018 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
06/08/2017 | SUPPL-35 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
06/18/2007 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
10/12/2004 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
01/23/2003 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
04/06/2000 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/06/2000 | SUPPL-19 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
08/04/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/04/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
09/16/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
05/12/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/07/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/12/1989 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/12/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/05/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
06/17/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/08/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/14/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/10/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
SCANDONEST PLAIN
INJECTABLE;INJECTION; 3%
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SCANDONEST PLAIN | MEPIVACAINE HYDROCHLORIDE | 3% | INJECTABLE;INJECTION | Prescription | No | AP | 088387 | DEPROCO |