Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 089410
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POLOCAINE MEPIVACAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription AP 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
12/01/1986 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
06/15/2010 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

05/24/2002 SUPPL-13 Labeling

Label is not available on this site.

03/08/2002 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/30/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/17/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/17/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/18/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/18/1992 SUPPL-3 Labeling

Label is not available on this site.

02/16/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/22/1989 SUPPL-1 Labeling

Label is not available on this site.

POLOCAINE

INJECTABLE;INJECTION; 2%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBOCAINE MEPIVACAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription Yes AP 012250 HOSPIRA
POLOCAINE MEPIVACAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 089410 FRESENIUS KABI USA
POLOCAINE-MPF MEPIVACAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 089409 FRESENIUS KABI USA

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