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Generated: November 16, 2018

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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 021665
Tradename:AMPHADASE
Applicant:Amphastar Pharm
Ingredient:hyaluronidase
Patents:0
Formulation / Manufacturing:see details
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
AMPHADASE hyaluronidase 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

Profile for product number 001

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

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