Timoptic in Ocudose

Basic Information

Product Name

Timoptic in Ocudose

FDA Product Code

0187-1496

Regulatory Information

NDC Product Code

0187-1496

Application Number

NDA019463

Marketing Category

C73594

Effective Date

January 6, 2020

Territorial Authority

USA

FDA Title

TIMOPTIC in OCUDOSE 0.25% and 0.5% (timolol maleate ophthalmic solution)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM

Code: 3980JIH2SW

Class Code: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM

Code: GR686LBA74

Class Code: IACT

Timolol Maleate

Quantity: 6.8 mg in 1 mL

Code: P8Y54F701R

Class Code: ACTIM

Sodium Hydroxide

Code: 55X04QC32I

Class Code: IACT

Water

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

TIMOLOL ANHYDROUS

Code: 5JKY92S7BR

Basic Information

Regulatory Information

Company Information

Active Ingredients

SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM

Sodium Hydroxide

Water

Active Moieties

TIMOLOL ANHYDROUS