Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL)
Zydus Lifesciences Limited
BUSPIRONE HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows: Generalized, persistent anxiety (of at least 1 month continual d
Buspirone Hydrochloride Tablets USP, 5 mg are white to off-white, capsule-shaped, flat- faced, beveled-edge tablets debossed with bisect on one side; one side of bisect is debossed with 'ZE' and another is debossed with '36' and other side is plain and are supplied as follows: NDC 65841-781-01 in bottle of 100 tablets NDC 65841-781-05 in bottle of 500 tablets NDC 65841-781-10 in bottle of 1000 tablets NDC 65841-781-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Buspirone Hydrochloride Tablets USP, 10 mg are white to off-white, capsule-shaped, flat-faced, beveled-edge tablets debossed with bisect on one side; one side of bisect is debossed with 'ZE' and another is debossed with '37' and other side is plain and are supplied as follows: NDC 65841-782-01 in bottle of 100 tablets NDC 65841-782-05 in bottle of 500 tablets NDC 65841-782-10 in bottle of 1000 tablets NDC 65841-782-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Buspirone Hydrochloride Tablets USP, 15 mg are white to off-white, capsule-shaped, flat-faced, beveled-edge tablets, bisected on one side and trisected on other side. The trisected side of tablet is debossed with '5' on each trisect segment. The bisected side is debossed with 'ZE', on one bisect and '38' on other bisect segment and are supplied as follows: NDC 65841-783-14 in bottle of 60 tablets NDC 65841-783-01 in bottle of 100 tablets NDC 65841-783-28 in bottle of 180 tablets NDC 65841-783-05 in bottle of 500 tablets NDC 65841-783-10 in bottle of 1000 tablets NDC 65841-783-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Buspirone Hydrochloride Tablets USP, 30 mg are white to off-white, capsule-shaped, flat-faced, beveled-edge tablets, bisected on one side and trisected on other side. The trisected side of tablet is debossed with '10' on each trisect segment. The bisected side is debossed with 'ZE', on one bisect and '39' on other bisect segment and are supplied as follows: NDC 65841-784-14 in bottle of 60 tablets NDC 65841-784-10 in bottle of 1000 tablets NDC 65841-784-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage: Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Desyrel® is the registered trademark of Bristol Myers Squibb Company. Synthroid® is the registered trademark of Abbott Laboratories
Abbreviated New Drug Application
Cadila Healthcare Limited ---------- Patient Instruction Sheet Buspirone Hydrochloride Tablets, USP HOW TO USE For 15 mg and 30 mg tablets Response to buspirone varies among individuals. Your physician may find it necessary to adjust your dosage to obtain the proper response. Each tablet is scored and can be broken accurately to provide any of the following dosages. To break a tablet accurately and easily, hold the tablet between your thumbs and index fingers close to the appropriate tablet score (groove) as shown in the photo. Then, with the tablet score facing you, apply pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088. Revised: 1/2020 Document Id: 7c614594-0b5a-4d84-9eaa-2a7ed584be00 34391-3 Set id: 1109dd63-6492-49b1-a383-3ab3a80cd6c7 Version: 4 Effective Time: 20200123 Cadila Healthcare Limited Læs hele dokumentet
BUSPIRONE HYDROCHLORIDE - BUSPIRONE HYDROCHLORIDE TABLET ZYDUS LIFESCIENCES LIMITED ---------- BUSPIRONE HYDROCHLORIDE TABLETS PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-781-01 in bottle of 100 tablets Buspirone Hydrochloride Tablets USP, 5 mg R only 100 tablets NDC 65841-842-01 in bottle of 100 tablets Buspirone Hydrochloride Tablets USP, 7.5 mg R only 100 tablets NDC 65841-782-01 in bottle of 100 tablets x x Buspirone Hydrochloride Tablets USP, 10 mg R only 100 tablets NDC 65841-783-01 in bottle of 100 tablets Buspirone Hydrochloride Tablets USP, 15 mg R only 100 tablets NDC 65841-784-14 in bottle of 60 tablets Buspirone Hydrochloride Tablets USP, 30 mg R only 60 tablets x x x BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:65841-781 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL) BUSPIRONE HYDROCHLORIDE 5 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) PRODUCT CHARACTERISTICS COLOR WHITE (white to off-white) SCORE 2 pieces SHAPE CAPSULE (CAPSULE) SIZE 8mm FLAVOR IMPRINT CODE Z E;36 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:65841-781- 01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/03/2014 2 NDC:65841-781- 05 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/03/2014 3 NDC:65841-781- 10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/03/2014 4 NDC:65841-781- 77 100 in 1 CARTON 05/03/2014 4 NDC:65841-781- 30 1 in 1 BLISTER PACK; Type 0: Not a Combination Product MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA078888 05/03/2014 B Læs hele dokumentet