TAFLUPROST solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

TAFLUPROST (UNII: 1O6WQ6T7G3) (TAFLUPROST - UNII:1O6WQ6T7G3)

Dostępny od:

The Ritedose Corporation

Droga podania:

OPHTHALMIC

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

TAFLUPROST- TAFLUPROST SOLUTION
THE RITEDOSE CORPORATION
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TAFLUPROST OPHTHALMIC SOLUTION, 0.0015%
NDC 0781-6184-87
Tafluprost Ophthalmic Solution 0.0015%
Single-Use Containers
Preservative-Free, Sterile
For Topical Application in the Eye
REFRIGERATE (2° to 8°C or 36° to 46°F)
Rx Only
30 Single-Use Containers:
6 Pouches x 5 Single-Use Containers
(0.3 mL each)
Sandoz A Novartis Division
TAFLUPROST OPHTHALMIC SOLUTION, 0.0015% CARTON
TAFLUPROST
tafluprost solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65302-062
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
TAFLUPROST (UNII: 1O6WQ6T7G3) (TAFLUPROST - UNII:1O6WQ6T7G3)
TAFLUPROST
0.0045 mg in 0.3 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYDROCHLORIC ACID (UNII: QTT17582CB)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65302-062-
05
6 in 1 CARTON
12/05/2022
1
5 in 1 POUCH
1
0.3 mL in 1 AMPULE; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA209040
12/05/2022
LABELER -
The Ritedose Corporation (837769546)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
The Ritedose
Corporation
837769546
analysis(65302-062) , label(65302-062) , manufacture(65302-062) ,
pack(65302-062)
The Ritedose Corporation
Revised: 12/2022