TIMOLOL MALEATE OPHTHALMIC SOLUTION- timolol maleate solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)

Dostupno od:

Holopack Verpackungstechnik GmbH

Administracija rute:

OPHTHALMIC

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

TIMOLOL MALEATE OPHTHALMIC SOLUTION- TIMOLOL MALEATE SOLUTION
HOLOPACK VERPACKUNGSTECHNIK GMBH
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TIMOLOL MALEATE OPHTHALMIC SOLUTION
TIMOLOL MALEATE OPHTHALMIC SOLUTION
Timolol Maleate Ophthalmic Solution
TIMOLOL MALEATE OPHTHALMIC SOLUTION
Timolol Maleate Ophthalmic Solution, USP
0.25%
Rx only
NCD Code 69918-602-60
Store at Room Temperature 15-30 ºC (59-86 ºF)
Mfd. For:
Amring Pharmaceuticals Inc.
Berwyn, PA 19312
www.amringusa.com
Mfd. By:
Holopack Verpackungstechnik GmbH
Bahnhofstr., 74429 Sulzbach-Laufen
Germany
Holopack Material No.: 011-01561
EXP 03/2022 LOT TEST02 QTY 30
(17)220331(10)TEST02(30)30
(01)30369918602609(21)123456789012
Printing date: 2022-04-06
Timolol Maleate Ophthalmic Solution, USP
0.5%
Rx only
NCD Code 69918-601-60
Store at Room Temperature 15-30 ºC (59-86 ºF)
Mfd. For:
Amring Pharmaceuticals Inc.
Berwyn, PA 19312
www.amringusa.com
Mfd. By:
Holopack Verpackungstechnik GmbH
Bahnhofstr., 74429 Sulzbach-Laufen
Germany
Holopack Material No.: 011-01561
EXP 03/2022 LOT TEST02 QTY 30
(17)220331(10)TEST02(30)30
(01)30369918601602(21)123456789012
Printing date: 2022-04-06
TIMOLOL MALEATE OPHTHALMIC SOLUTION
timolol maleate solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:60940-038
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS -
UNII:5JKY92S7BR)
TIMOLOL ANHYDROUS
5 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
TROMETHAMINE (UNII: 023C2WHX2V)
BENZODODECINIUM BROMIDE (UNII: IRY12B2TQ6)
MANNITOL (UNII: 3OWL53L36A)
GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:60940-
038-01
6 in 1 CARTON
02/04/2022
1
10 in 1 POUCH
1
5 mL in 1 BOTTLE, DISPENSING; Type 0: Not a
Combination Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA212592
02/0