U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091087
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AB 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
04/04/2022 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/091087Orig1s000ltr.pdf

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC; 0.2%;EQ 0.5% BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AB 215230 ALEMBIC
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AB 091442 APOTEX
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AB 201949 FLORIDA
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AB 214987 GLENMARK PHARMS LTD
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AB 091087 SANDOZ
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AB 091086 SENTISS
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AB 216114 SOMERSET
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AB 215598 UPSHER SMITH LABS
COMBIGAN BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AB 021398 ABBVIE
Back to Top