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Details for New Drug Application (NDA): 021665

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NDA 021665 describes AMPHADASE, which is a drug marketed by Amphastar Pharm and is included in one NDA. It is available from one supplier. Additional details are available on the AMPHADASE profile page.

The generic ingredient in AMPHADASE is hyaluronidase. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the hyaluronidase profile page.

Summary for NDA: 021665

Amphastar Pharm

Pharmacology for NDA: 021665

Ingredient-typeGlycoside Hydrolases

Suppliers and Packaging for NDA: 021665

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 021665 NDA Amphastar Pharmaceuticals, Inc. 0548-9090 0548-9090-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0548-9090-10) > 1 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength150 UNITS/ML
Approval Date:Oct 26, 2004TE:RLD:Yes

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