Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086283
Company: INTL MEDICATION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% JELLY;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
08/07/1979 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
09/19/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/25/1993 SUPPL-14 Labeling

Label is not available on this site.

12/17/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/08/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/10/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/05/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/16/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/16/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

LIDOCAINE HYDROCHLORIDE

JELLY;TOPICAL; 2%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYDO LIDOCAINE HYDROCHLORIDE 2% JELLY;TOPICAL Prescription No AT 201094 SAGENT PHARMS
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% JELLY;TOPICAL Prescription No AT 040433 AKORN
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% JELLY;TOPICAL Prescription No AT 086283 INTL MEDICATION
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% JELLY;TOPICAL Prescription No AT 040837 WATSON LABS INC
XYLOCAINE LIDOCAINE HYDROCHLORIDE 2% JELLY;TOPICAL Prescription Yes AT 008816 OAK PHARMS

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