Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086724
Company: TARO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE LIDOCAINE 5% OINTMENT;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
08/17/1981 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
11/02/2018 SUPPL-35 Labeling-Package Insert

Label is not available on this site.
11/02/2018 SUPPL-33 Labeling-Package Insert

Label is not available on this site.
09/02/2016 SUPPL-28 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
01/24/2006 SUPPL-20 Labeling

Label is not available on this site.
02/16/1993 SUPPL-14 Labeling

Label is not available on this site.
09/22/1989 SUPPL-13 Labeling

Label is not available on this site.
06/30/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
02/24/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
08/14/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
02/25/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
02/25/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
02/25/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
06/12/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
04/05/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
03/24/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

LIDOCAINE

OINTMENT;TOPICAL; 5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 211469 ALEOR DERMACEUTICALS
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 207810 ALKEM LABS LTD
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 206297 AMNEAL PHARMS
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 211019 COSETTE
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 208660 DR REDDYS
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 080198 FOUGERA PHARMS INC
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 206498 GLENMARK PHARMS LTD
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 211697 MACLEODS PHARMS LTD
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 040911 SEPTODONT INC
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 210958 STRIDES PHARMA
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 086724 TARO
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 205318 TELIGENT
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 208822 VITRUVIAS THERAP

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