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BUSPIRONE HYDROCHLORIDE

Approved
Approval ID

b3240f73-c506-4591-a441-3bfab2fb1281

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 19, 2010

Manufacturers
FDA

STAT RX USA LLC

DUNS: 786036330

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

BUSPIRONE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16590-727
Application NumberANDA075467
Product Classification
M
Marketing Category
C73584
G
Generic Name
BUSPIRONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 19, 2010
FDA Product Classification

INGREDIENTS (6)

BUSPIRONE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

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BUSPIRONE HYDROCHLORIDE - FDA Drug Approval Details