Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062452
Company: ALLERGAN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENOPTIC GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/10/1984 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
11/15/2002 SUPPL-22 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
07/03/2002 SUPPL-21 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
08/15/2001 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.
02/20/2004 SUPPL-19 Labeling

Label is not available on this site.
12/08/2000 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.
10/16/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
02/24/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
10/22/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
04/03/1998 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
01/31/1995 SUPPL-12 Labeling

Label is not available on this site.
07/01/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
09/27/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
09/27/1993 SUPPL-9 Labeling

Label is not available on this site.
02/28/1992 SUPPL-8 Labeling

Label is not available on this site.
02/26/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
04/05/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
04/11/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
11/22/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

GENOPTIC

SOLUTION/DROPS;OPHTHALMIC; EQ 0.3% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GENOPTIC GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 062452 ALLERGAN
GENTAK GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 064163 AKORN
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 062635 AKORN
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 064048 BAUSCH AND LOMB
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 065121 PERRIGO CO TENNESSEE
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 062196 SANDOZ INC

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