Drugs@FDA: FDA Approved Drug Products

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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

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