Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077259
Company: FDC LTD
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 No
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT1 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
04/30/2008 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
03/25/2010 SUPPL-4 Labeling-Container/Carton Labels

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

SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 074466 AKORN
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 074516 AKORN
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 074776 BAUSCH AND LOMB
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 077259 FDC LTD
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 075163 HI TECH PHARMA
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 074747 PACIFIC PHARMA
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 074262 SANDOZ INC
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 078771 WOCKHARDT
TIMOPTIC TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT1 018086 VALEANT PHARMS INTL

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