CLINDAMYCIN HYDROCHLORIDE capsule, gelatin coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C)

Предлага се от:

Zydus Lifesciences Limited

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician,a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING , before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis,

Каталог на резюме:

Clindamycin hydrochloride capsules, USP are available in the following strengths, colors and sizes: Clindamycin hydrochloride capsules, USP equivalent to 75 mg of clindamycin are white to off white granular powder filled in size '2' hard gelatin capsules with blue colored cap printed with "Z-89" in black ink and blue colored body printed with "75 mg" in black ink and are supplied as follows. NDC 70771-1136-8 in bottles of 16 capsules NDC 70771-1136-1 in bottles of 100 capsules NDC 70771-1136-5 in bottles of 500 capsules Clindamycin hydrochloride capsules, USP equivalent to 150 mg of clindamycin are white to off white granular powder filled in size '1' hard gelatin capsules with blue colored cap printed with "Z-90" in black ink and blue colored body printed with "150 mg" in black ink and are supplied as follows. NDC 70771-1137-8 in bottles of 16 capsules NDC 70771-1137-1 in bottles of 100 capsules NDC 70771-1137-5 in bottles of 500 capsules Clindamycin hydrochloride capsules, USP equivalent to 300 mg of clindamycin are white to off white granular powder filled in size '0' hard gelatin capsules with blue colored cap printed with "Z-91" in black ink and blue colored body printed with "300 mg" in black ink and are supplied as follows. NDC 70771-1183-8 in bottles of 16 capsules NDC 70771-1183-1 in bottles of 100 capsules NDC 70771-1183-5 in bottles of 500 capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

CLINDAMYCIN HYDROCHLORIDE - CLINDAMYCIN HYDROCHLORIDE CAPSULE, GELATIN
COATED
ZYDUS LIFESCIENCES LIMITED
----------
CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1136-1 in bottle of 100 Capsules
Clindamycin Hydrochloride Capsules USP, 75 mg
Rx only
100 Capsules
NDC 70771-1137-1 in bottle of 100 Capsules
Clindamycin Hydrochloride Capsules USP, 150 mg
Rx only
100 Capsules
NDC 70771-1183-1 in bottle of 100 Capsules
Clindamycin Hydrochloride Capsules USP, 300 mg
Rx only
100 Capsules
CLINDAMYCIN HYDROCHLORIDE
clindamycin hydrochloride capsule, gelatin coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1136
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN -
UNII:3U02EL437C)
CLINDAMYCIN
75 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
BLUE (BLUE (CAP)) , BLUE (BLUE (BODY))
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
18mm
FLAVOR
IMPRINT CODE
Z ;89
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1136-8
16 in 1 BOTTLE; Type 0: Not a Combination
Product
11/23/2017
2
NDC:70771-
1136-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
11/23/2017
3
NDC:70771-
1136-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
11/23/2017
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA065217
11/17/2017
CLINDAMYCIN HYDROCHLORIDE
clindamycin hydrochloride capsule, gelatin coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1137
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT