Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 083173
Company: INTL MEDICATION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription AP No No
LIDOCAINE HYDROCHLORIDE LIDOCAINE 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
09/17/1975 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
09/19/2002 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

09/01/2005 SUPPL-36 Labeling

Label is not available on this site.

04/06/2001 SUPPL-34 Labeling

Label is not available on this site.

09/19/1995 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/01/1994 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/14/1998 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/29/1993 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/30/1993 SUPPL-28 Labeling

Label is not available on this site.

12/17/1992 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

07/08/1993 SUPPL-26 Labeling

Label is not available on this site.

07/08/1993 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/08/1993 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/27/1992 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/20/1991 SUPPL-21 Labeling

Label is not available on this site.

11/26/1991 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/23/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/23/1992 SUPPL-18 Labeling

Label is not available on this site.

10/19/1993 SUPPL-14 Labeling

Label is not available on this site.

07/10/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/16/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/11/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/16/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION; 1%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 207182 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 083158 HOSPIRA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 088329 HOSPIRA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 083173 INTL MEDICATION
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 080850 LUITPOLD
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 091564 LUITPOLD PHARMS INC
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 091056 MYLAN LABS LTD
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 091058 MYLAN LABS LTD
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 088586 FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 088299 HOSPIRA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 203040 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 203082 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 080404 FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 080408 HOSPIRA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 040302 HOSPIRA
XYLOCAINE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA
XYLOCAINE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription Yes AP 016801 FRESENIUS KABI USA

INJECTABLE;INJECTION; 2%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 207182 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 040078 HOSPIRA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 083158 HOSPIRA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 088294 HOSPIRA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 083173 INTL MEDICATION
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 202242 MYLAN LABS LTD
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 088327 HOSPIRA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 203040 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 203082 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 017584 FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 080404 FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 090665 MYLAN LABS LTD
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 040302 HOSPIRA
XYLOCAINE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA
XYLOCAINE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription Yes AP 016801 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