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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 204024


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NDA 204024 describes FOSAMPRENAVIR CALCIUM, which is a drug marketed by Mylan and Sun Pharm and is included in two NDAs. It is available from two suppliers. Additional details are available on the FOSAMPRENAVIR CALCIUM profile page.

The generic ingredient in FOSAMPRENAVIR CALCIUM is fosamprenavir calcium. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fosamprenavir calcium profile page.
Summary for 204024
Tradename:FOSAMPRENAVIR CALCIUM
Applicant:Sun Pharm
Ingredient:fosamprenavir calcium
Patents:0
Suppliers and Packaging for NDA: 204024
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSAMPRENAVIR CALCIUM fosamprenavir calcium TABLET;ORAL 204024 ANDA Sun Pharmaceutical Industries, Inc. 63304-583 63304-583-01 100 TABLET, COATED in 1 BOTTLE (63304-583-01)
FOSAMPRENAVIR CALCIUM fosamprenavir calcium TABLET;ORAL 204024 ANDA Sun Pharmaceutical Industries, Inc. 63304-583 63304-583-30 30 TABLET, COATED in 1 BOTTLE (63304-583-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 700MG BASE
Approval Date:Nov 20, 2019TE:ABRLD:No

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