Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072668
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIMOLOL MALEATE TIMOLOL MALEATE 20MG TABLET;ORAL Prescription AB No Yes
TIMOLOL MALEATE TIMOLOL MALEATE 5MG TABLET;ORAL Prescription AB No No
TIMOLOL MALEATE TIMOLOL MALEATE 10MG 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
06/08/1990 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
08/14/2003 SUPPL-12 Labeling

Label is not available on this site.

06/06/2003 SUPPL-11 Labeling

Label is not available on this site.

01/17/2001 SUPPL-10 Labeling

Label is not available on this site.

10/01/1999 SUPPL-9 Labeling

Label is not available on this site.

04/23/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/06/1995 SUPPL-6 Labeling

Label is not available on this site.

11/16/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/14/1993 SUPPL-3 Labeling

Label is not available on this site.

07/10/1992 SUPPL-2 Labeling

Label is not available on this site.

07/10/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

TIMOLOL MALEATE

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

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

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