Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088387
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English