Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074747
Company: PACIFIC PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
03/25/1997 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
10/06/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

04/08/2005 SUPPL-12 Labeling

Label is not available on this site.

07/14/2003 SUPPL-10 Labeling

Label is not available on this site.

11/15/2002 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/03/2002 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

01/07/2002 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

08/15/2001 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

12/08/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

03/29/2000 SUPPL-2 Labeling

Label is not available on this site.

12/16/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

TIMOLOL MALEATE

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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