NDC Code(s) : 60505-0597-1, 60505-0597-2, 60505-0597-3, 60505-0598-1, 60505-0598-2, 60505-0598-3
Packager : Apotex Corp.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Timolol MaleateTimolol Maleate SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-0597
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Timolol Maleate(UNII: P8Y54F701R)
(Timolol - UNII:817W3C6175) 		Timolol2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC(UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC(UNII: 3980JIH2SW)
Sodium Chloride(UNII: 451W47IQ8X)
Benzalkonium Chloride(UNII: F5UM2KM3W7)0.1 mg in 1 mL
Sodium Hydroxide(UNII: 55X04QC32I)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-0597-11 in 1 CARTON
15 mL in 1 BOTTLE
2NDC:60505-0597-21 in 1 CARTON
210 mL in 1 BOTTLE
3NDC:60505-0597-31 in 1 CARTON
315 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077259 07/15/2011
Timolol MaleateTimolol Maleate SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-0598
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Timolol Maleate(UNII: P8Y54F701R)
(Timolol - UNII:817W3C6175) 		Timolol5.0 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE(UNII: E1W4N241FO)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE(UNII: 5QWK665956)
Sodium Chloride(UNII: 451W47IQ8X)
Benzalkonium Chloride(UNII: F5UM2KM3W7)0.1 mg in 1 mL
Sodium Hydroxide(UNII: 55X04QC32I)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-0598-11 in 1 CARTON
15 mL in 1 BOTTLE
2NDC:60505-0598-21 in 1 CARTON
210 mL in 1 BOTTLE
3NDC:60505-0598-31 in 1 CARTON
315 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077259 07/15/2011

PRINCIPAL DISPLAY PANEL

Rx Only 5mL

NDC 60505-0597-1

Timolol Maleate

STERILE OPTHALMIC SOLUTION USP

0.25%

Timolol Equivalent (Timolol Maleate 3.4 mg/mL)

For Topical Application In The Eye

APOTEX CORP.

0.25% 5 mL Product Container

PRINCIPAL DISPLAY PANEL

Rx Only 5mL

NDC 60505-0598-1

Timolol Maleate

STERILE OPTHALMIC SOLUTION USP

0.5%

Timolol Equivalent (Timolol Maleate 6.8 mg/mL)

For Topical Application In The Eye

APOTEX CORP.

0.5% 5 mL Product Container