Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080504
Company: BELMORA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Discontinued None No No
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.01MG/ML;2% INJECTABLE;INJECTION Discontinued None No No
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.02MG/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
02/23/1972 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
10/01/1992 SUPPL-34 Labeling

Label is not available on this site.

10/11/1989 SUPPL-33 Labeling

Label is not available on this site.

11/08/1988 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/23/1988 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/23/1987 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/09/1985 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/09/1985 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/19/1983 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

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