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Generated: February 17, 2019

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Details for New Drug Application (NDA): 063206

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NDA 063206 describes AMPHOTERICIN B, which is a drug marketed by Abbott, Abraxis Pharm, Teva Parenteral, and X Gen Pharms, and is included in four NDAs. It is available from one supplier. Additional details are available on the AMPHOTERICIN B profile page.

The generic ingredient in AMPHOTERICIN B is amphotericin b. There are fifteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amphotericin b profile page.
Summary for 063206
Applicant:X Gen Pharms
Ingredient:amphotericin b
Formulation / Manufacturing:see details
Pharmacology for NDA: 063206
Medical Subject Heading (MeSH) Categories for 063206
Suppliers and Packaging for NDA: 063206
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPHOTERICIN B amphotericin b INJECTABLE;INJECTION 063206 ANDA X-GEN Pharmaceuticals, Inc. 39822-1055 39822-1055-5 10 mL in 1 VIAL (39822-1055-5)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/VIAL
Approval Date:Apr 29, 1992TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
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US Army

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