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Fluphenazine Decanoate

Fluphenazine Decanoate Injection, USP

Approved
Approval ID

73d85626-abf8-493a-bb8c-ce9a4f2ae08b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 16, 2010

Manufacturers
FDA

TYA Pharmaceuticals

DUNS: 938389038

Products 1

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

FLUPHENAZINE DECANOATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code64725-0272
Application NumberANDA071413
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUPHENAZINE DECANOATE
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateDecember 16, 2010
FDA Product Classification

INGREDIENTS (3)

BENZYL ALCOHOLInactive
Quantity: 12 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
FLUPHENAZINE DECANOATEActive
Quantity: 25 mg in 1 mL
Code: FMU62K1L3C
Classification: ACTIB
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT

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Fluphenazine Decanoate - FDA Drug Approval Details