Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086364
Company: INTL MEDICATION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LARYNG-O-JET KIT LIDOCAINE HYDROCHLORIDE 4% SOLUTION;TOPICAL Prescription AT 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
03/06/1980 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
08/18/2015 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

12/17/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/19/1995 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/20/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/14/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/29/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/19/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

09/03/1992 SUPPL-19 Labeling

Label is not available on this site.

08/29/1989 SUPPL-18 Labeling

Label is not available on this site.

10/19/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/01/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/13/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/12/1982 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/01/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

LARYNG-O-JET KIT

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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