CLOBETASOL PROPIONATE spray

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)

Dostopno od:

Zydus Lifesciences Limited

INN (mednarodno ime):

CLOBETASOL PROPIONATE

Sestava:

CLOBETASOL PROPIONATE 0.05 g in 1 mL

Pot uporabe:

TOPICAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Clobetasol propionate spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. Patients should be instructed to use clobetasol propionate spray, 0.05% for the minimum amount of time necessary to achieve the desired results [see Dosage and Administration (2) ]. Use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations. [see Use in Specific Populations (8.4)] Clobetasol propionate spray, 0.05% should not be used on the face, axillae, or groin.  Clobetasol propionate spray, 0.05% should not be used if there is atrophy at the treatment site. Clobetasol propionate spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis. None. Risk Summary There are no available data on

Povzetek izdelek:

Clobetasol propionate spray, 0.05% is a clear, colorless liquid, filled in white HDPE bottle fitted with white polypropylene cap and are supplied as follows: 2 fl oz/59 mL NDC 70771-1080-6 4.25 fl oz/125 mL NDC 70771-1080-7 Storage Keep tightly closed. Store under controlled room temperature conditions 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F). Do not freeze, refrigerate or store above 30°C.  Spray is flammable; avoid heat, flame or smoking when using this product.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE SPRAY
ZYDUS LIFESCIENCES LIMITED
----------
CLOBETASOL PROPIONATE SPRAY, 0.05%
Clobetasol Propinate Spray, 0.05%
NDC 70771-1080-6
2 fl. oz. (59 mL)
Clobetasol Propinate Spray, 0.05%
NDC 70771-1080-7
4.25 fl. oz. (125 mL)
CLOBETASOL PROPIONATE
clobetasol propionate spray
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1080
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL -
CLOBETASOL
0.05 g
Zydus Lifesciences Limited
UNII:ADN79D536H)
PROPIONATE
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALCOHOL (UNII: 3K9958V90M)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
UNDECYLENIC ACID (UNII: K3D86KJ24N)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1080-7
1 in 1 CARTON
07/12/2017
1
125 mL in 1 BOTTLE; Type 0: Not a Combination
Product
2
NDC:70771-
1080-6
1 in 1 CARTON
07/12/2017
2
59 mL in 1 BOTTLE; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA206378
07/12/2017
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
650650802
ANALYSIS(70771-1080) , MANUFACTURE(70771-1080)
Revised: 10/2022