Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074261
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% 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
04/28/1995 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
04/08/2005 SUPPL-17 Labeling

Label is not available on this site.

05/21/2004 SUPPL-16 Labeling

Label is not available on this site.

03/21/2003 SUPPL-14 Labeling

Label is not available on this site.

10/01/2002 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/28/2002 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/05/2002 SUPPL-11 Labeling

Label is not available on this site.

04/07/2000 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/28/2000 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/27/1999 SUPPL-8 Labeling

Label is not available on this site.

03/23/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/07/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/28/1999 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/20/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/27/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/27/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/04/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.25% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 074778 BAUSCH AND LOMB
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 077259 FDC LTD
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 074746 PACIFIC PHARMA
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 074261 SANDOZ INC
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078771 WOCKHARDT
TIMOPTIC TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 018086 VALEANT PHARMS INTL

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