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Details for New Drug Application (NDA): 016273

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NDA 016273 describes LASIX, which is a drug marketed by Sanofi Aventis Us and Us Pharm Holdings and is included in three NDAs. It is available from two suppliers. Additional details are available on the LASIX profile page.

The generic ingredient in LASIX is furosemide. There are twenty-one drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the furosemide profile page.

Summary for NDA: 016273

Tradename:
LASIX
Applicant:
Us Pharm Holdings
Ingredient:
furosemide
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 016273

Suppliers and Packaging for NDA: 016273

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LASIX
furosemide
TABLET;ORAL 016273 NDA Sanofi-Aventis U.S. LLC 0039-0060 0039-0060-13 100 TABLET in 1 BOTTLE (0039-0060-13)
LASIX
furosemide
TABLET;ORAL 016273 NDA Sanofi-Aventis U.S. LLC 0039-0060 0039-0060-50 500 TABLET in 1 BOTTLE (0039-0060-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 016273

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Us Pharm Holdings
LASIX
furosemide
TABLET;ORAL016273-002Approved Prior to Jan 1, 19824,324,779► subscribe
Us Pharm Holdings
LASIX
furosemide
TABLET;ORAL016273-003Approved Prior to Jan 1, 19824,324,779► subscribe
Us Pharm Holdings
LASIX
furosemide
TABLET;ORAL016273-001Approved Prior to Jan 1, 19824,324,779► subscribe
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