Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087872
Company: WOCKHARDT BIO AG

Products on ANDA 087872

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087872

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.

Therapeutic Equivalents for ANDA 087872

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	216780	RUBICON
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION;ORAL	Prescription	No	AT	087872	WOCKHARDT BIO AG
LIDOCAINE HYDROCHLORIDE VISCOUS	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION;ORAL	Prescription	No	AT	040708	CHARTWELL MOLECULAR
LIDOCAINE HYDROCHLORIDE VISCOUS	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION;ORAL	Prescription	No	AT	218138	PAI HOLDINGS PHARM
LIDOCAINE VISCOUS	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION;ORAL	Prescription	No	AT	088802	HIKMA