Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062480
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENTACIDIN GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC 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
03/30/1984 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
04/19/2001 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

02/12/1999 SUPPL-7 Labeling

Label is not available on this site.

08/22/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/05/1994 SUPPL-5 Labeling

Label is not available on this site.

06/10/1994 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/30/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/19/1993 SUPPL-2 Labeling

Label is not available on this site.

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