Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074778
Company: BAUSCH AND LOMB

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

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
12/09/2002 SUPPL-18 Labeling

Label is not available on this site.
08/22/2002 SUPPL-17 Labeling

Label is not available on this site.
11/27/2001 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
03/07/2001 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
10/05/2000 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
06/27/2000 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
05/15/2000 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
08/24/1999 SUPPL-10 Labeling

Label is not available on this site.
04/28/2000 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
05/18/2000 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
06/07/1999 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
01/13/1999 SUPPL-6 Labeling

Label is not available on this site.
06/25/1998 SUPPL-5 Labeling

Label is not available on this site.
03/27/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
01/29/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
03/06/1998 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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