Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080429
Company: BIONPHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANESTACON LIDOCAINE HYDROCHLORIDE 2% JELLY;TOPICAL 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
04/11/1974 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
01/16/1996 SUPPL-18 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/12/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/12/1991 SUPPL-14 Labeling

Label is not available on this site.

06/05/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/16/1984 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/13/1983 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/08/1983 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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