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Details for New Drug Application (NDA): 016466

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NDA 016466 describes ARISTOSPAN, which is a drug marketed by Sandoz and is included in one NDA. It is available from one supplier. Additional details are available on the ARISTOSPAN profile page.

The generic ingredient in ARISTOSPAN is triamcinolone hexacetonide. There are forty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the triamcinolone hexacetonide profile page.

Summary for NDA: 016466

Suppliers and Packaging for NDA: 016466

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
triamcinolone hexacetonide
INJECTABLE;INJECTION 016466 NDA Sandoz Inc 0781-3084 0781-3084-75 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3084-75) > 5 mL in 1 VIAL, MULTI-DOSE
triamcinolone hexacetonide
INJECTABLE;INJECTION 016466 NDA Sandoz Inc 0781-3085 0781-3085-71 1 VIAL in 1 CARTON (0781-3085-71) > 1 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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