Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087872
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% SOLUTION;ORAL 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
11/18/1982 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-24 Labeling-Package Insert

Label is not available on this site.

12/01/2014 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

12/18/2003 SUPPL-22 Labeling

Label is not available on this site.

01/10/2003 SUPPL-21 Labeling

Label is not available on this site.

12/02/1996 SUPPL-17 Labeling

Label is not available on this site.

12/02/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/02/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/02/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/02/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/12/1994 SUPPL-12 Labeling

Label is not available on this site.

10/10/1991 SUPPL-11 Labeling

Label is not available on this site.

04/04/1990 SUPPL-10 Labeling

Label is not available on this site.

09/08/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/14/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/30/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/18/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/18/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/03/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

LIDOCAINE HYDROCHLORIDE

SOLUTION;ORAL; 2%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% SOLUTION;ORAL Prescription No AT 040014 HI TECH PHARMA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% SOLUTION;ORAL Prescription No AT 087872 WOCKHARDT BIO AG
LIDOCAINE VISCOUS LIDOCAINE HYDROCHLORIDE 2% SOLUTION;ORAL Prescription No AT 088802 HIKMA

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