BUPROPION tablet, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)

Tilgjengelig fra:

Zydus Lifesciences Limited

INN (International Name):

BUPROPION HYDROCHLORIDE

Sammensetning:

BUPROPION HYDROCHLORIDE 300 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4 week controlled inpatient trials and one 6 week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8 week study of acute treatment [see Clinical Studies (14.1) ]. Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in ad

Produkt oppsummering:

Bupropion Hydrochloride Extended-release Tablets USP (XL), 150 mg are creamy-white to pale-yellow, round, biconvex, beveled-edge coated-tablets imprinted with '353' in black ink on one side and plain on other side and are supplied as follows: NDC 65841-836-06 in bottle of 30 tablets NDC 65841-836-16 in bottle of 90 tablets NDC 65841-836-05 in bottle of 500 tablets NDC 65841-836-10 in bottle of 1000 tablets Bupropion Hydrochloride Extended-release Tablets USP (XL), 300 mg are creamy-white to pale-yellow, round, biconvex, coated-tablets imprinted with '354' in black ink on one side and plain on other side and are supplied as follows: NDC 65841-780-06 in bottle of 30 tablets NDC 65841-780-16 in bottle of 90 tablets NDC 65841-780-05 in bottle of 500 tablets NDC 65841-780-10 in bottle of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Bupropion Hydrochloride Extended-release Tablets USP (XL) may have an odor.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Zydus Lifesciences Limited
----------
Manufactured by:
Cadila Healthcare Ltd.
India.
SPL MEDGUIDE
Revised: 9/2023
Document Id: 30b6520d-ee87-4a71-83eb-87448080151b
34391-3
Set id: 78d34aad-9d4f-48c4-91eb-536e31c6b6c9
Version: 10
Effective Time: 20230920
Zydus Lifesciences Limited

Preparatomtale

BUPROPION- BUPROPION TABLET, EXTENDED RELEASE
ZYDUS LIFESCIENCES LIMITED
----------
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL)
Manufactured by:
Cadila Healthcare Ltd.
India.
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-780-05
Bupropion Hydrochloride Extended-release Tablets USP (XL), 300 mg
500 Tablets
Rx only
NDC 65841-836-05
Bupropion Hydrochloride Extended-release Tablets USP (XL), 150 mg
500 Tablets
Rx only
Rx only
BUPROPION
bupropion tablet, extended release
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-780
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION -
UNII:01Z G3TPX31)
BUPROPION
HYDROCHLORIDE
300 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID (UNII: 1CS02G8656)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
POVIDONE (UNII: FZ989GH94E)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
AMMONIA (UNII: 5138Q19F1X)
PRODUCT CHARACTERISTICS
COLOR
YELLOW (CREAMY WHITE TO PALE YELLOW)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
9mm
FLAVOR
IMPRINT CODE
354
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-780-
06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
02/15/2014
2
NDC:65841-780-
16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
02/15/2014
3
NDC:65841-780-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
02/15/2014
4
NDC:65841-780-
10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
02/15/2014
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA201567
02/15/2014
BUPROPION
bupr