Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017702
Company: INTL MEDICATION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 20% INJECTABLE;INJECTION Prescription AP No No
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 4% 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
12/20/1976 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/18/1995 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/06/1993 SUPPL-24 Labeling

Label is not available on this site.

12/11/1992 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1992 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1993 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1992 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1992 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/17/1993 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1986 SUPPL-10 Labeling

Label is not available on this site.

07/11/1978 SUPPL-4 Labeling

Label is not available on this site.

07/11/1978 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/24/1977 SUPPL-2 Labeling

Label is not available on this site.

08/24/1977 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

INJECTABLE;INJECTION; 20%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 20% INJECTABLE;INJECTION Prescription No AP 083158 HOSPIRA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 20% INJECTABLE;INJECTION Prescription No AP 017702 INTL MEDICATION
XYLOCAINE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 20% INJECTABLE;INJECTION Prescription Yes AP 016801 FRESENIUS KABI USA

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