Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081318
Company: COSETTE PHARMS NC

Products on ANDA 081318

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	JELLY;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 081318

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/1993	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
09/26/2025	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
12/06/2005	SUPPL-19	Labeling		Label is not available on this site.
02/14/2002	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
02/14/2002	SUPPL-13	Manufacturing (CMC)-Facility		Label is not available on this site.
10/31/2001	SUPPL-12	Manufacturing (CMC)-Facility		Label is not available on this site.
10/31/2001	SUPPL-11	Manufacturing (CMC)-Facility		Label is not available on this site.
10/31/2001	SUPPL-10	Manufacturing (CMC)-Facility		Label is not available on this site.
01/23/2002	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
02/26/2001	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
03/23/1999	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
11/23/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/15/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/07/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/24/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/31/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.