Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088803
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 4% SOLUTION;TOPICAL Prescription AT 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
04/03/1985 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
06/30/2008 SUPPL-13 Labeling

Label is not available on this site.

03/27/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/2000 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/28/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/18/1991 SUPPL-7 Labeling

Label is not available on this site.

03/04/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/31/1989 SUPPL-5 Labeling

Label is not available on this site.

09/27/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/27/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/01/1988 SUPPL-2 Bioequivalence

Label is not available on this site.

10/17/1988 SUPPL-1 Labeling

Label is not available on this site.

LIDOCAINE HYDROCHLORIDE

SOLUTION;TOPICAL; 4%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LARYNG-O-JET KIT LIDOCAINE HYDROCHLORIDE 4% SOLUTION;TOPICAL Prescription No AT 086364 INTL MEDICATION
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 4% SOLUTION;TOPICAL Prescription No AT 204494 TELIGENT PHARMA INC
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 4% SOLUTION;TOPICAL Prescription No AT 088803 WEST-WARD PHARMS INT

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