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): 207556
Company: ELYSIUM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIMOLOL MALEATE TIMOLOL MALEATE 5MG TABLET;ORAL Prescription AB No No
TIMOLOL MALEATE TIMOLOL MALEATE 10MG TABLET;ORAL Prescription AB No No
TIMOLOL MALEATE TIMOLOL MALEATE 20MG TABLET;ORAL 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
05/02/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

TIMOLOL MALEATE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TIMOLOL MALEATE TIMOLOL MALEATE 5MG TABLET;ORAL Prescription No AB 207556 ELYSIUM
TIMOLOL MALEATE TIMOLOL MALEATE 5MG TABLET;ORAL Prescription No AB 072668 MYLAN

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TIMOLOL MALEATE TIMOLOL MALEATE 10MG TABLET;ORAL Prescription No AB 207556 ELYSIUM
TIMOLOL MALEATE TIMOLOL MALEATE 10MG TABLET;ORAL Prescription No AB 072668 MYLAN

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TIMOLOL MALEATE TIMOLOL MALEATE 20MG TABLET;ORAL Prescription No AB 207556 ELYSIUM
TIMOLOL MALEATE TIMOLOL MALEATE 20MG TABLET;ORAL Prescription No AB 072668 MYLAN
Back to Top