Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080406
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.01MG/ML;1% INJECTABLE;INJECTION Discontinued None No No
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.01MG/ML;2% INJECTABLE;INJECTION Discontinued None 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
03/13/1972 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
11/23/1998 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

09/27/1996 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

03/06/1996 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

07/18/1994 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

07/31/1991 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

09/13/1990 SUPPL-38 Labeling

Label is not available on this site.

05/24/1990 SUPPL-37 Labeling

Label is not available on this site.

04/06/1989 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/06/1989 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

11/16/1988 SUPPL-34 Labeling

Label is not available on this site.

09/27/1989 SUPPL-33 Labeling

Label is not available on this site.

11/03/1986 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

09/29/1982 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

05/31/1983 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

11/23/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

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