Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 084850
Company: BELMORA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE 0.05MG/ML;2% 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
01/22/1976 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
08/10/1994 SUPPL-31 Labeling

Label is not available on this site.

12/22/1993 SUPPL-30 Labeling

Label is not available on this site.

08/25/1993 SUPPL-29 Labeling

Label is not available on this site.

03/24/1993 SUPPL-28 Labeling

Label is not available on this site.

10/31/1989 SUPPL-27 Labeling

Label is not available on this site.

08/04/1988 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/04/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/03/1987 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/24/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/24/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/02/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

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