CLOBETASOL PROPIONATE ointment

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Zydus Lifesciences Limited

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Clobetasol propionate ointment is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Clobetasol propionate ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

ملخص المنتج:

Clobetasol Propionate Ointment USP, 0.05% is supplied in: NDC 70771-1209-1in tube of 15 g NDC 70771-1209-2 in tube of 30 g NDC 70771-1209-4 in tube of 45 g NDC 70771-1209-3 in tube of 60 g Store at controlled room temperature 15°-30°C (59°-86°F). DO NOT REFRIGERATE. Call you doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please address medical inquiries to, ([e-mail]) Tel.: [phone].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE OINTMENT
ZYDUS LIFESCIENCES LIMITED
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CLOBETASOL PROPIONATE OINTMENT USP, 0.05%
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1209-1
Clobetasol Propionate Ointment USP, 0.05%
Rx only
15 g
CLOBETASOL PROPIONATE
clobetasol propionate ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1209
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
Zydus Lifesciences Limited
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL -
UNII:ADN79D536H)
CLOBETASOL
PROPIONATE
0.5 mg
in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
PETROLATUM (UNII: 4T6H12BN9U)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1209-1
1 in 1 CARTON
03/22/2018
1
15 g in 1 TUBE; Type 0: Not a Combination
Product
2
NDC:70771-
1209-2
1 in 1 CARTON
03/22/2018
2
30 g in 1 TUBE; Type 0: Not a Combination
Product
3
NDC:70771-
1209-4
1 in 1 CARTON
03/22/2018
3
45 g in 1 TUBE; Type 0: Not a Combination
Product
4
NDC:70771-
1209-3
1 in 1 CARTON
03/22/2018
4
60 g in 1 TUBE; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA210199
03/22/2018
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (650650802)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
650650802
ANALYSIS(70771-1209) , MANUFACTURE(70771-1209)
Revised: 8/2022