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Details for New Drug Application (NDA): 021572

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NDA 021572 describes CUBICIN RF, which is a drug marketed by Cubist Pharms Llc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the CUBICIN RF profile page.

The generic ingredient in CUBICIN RF is daptomycin. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the daptomycin profile page.

Summary for NDA: 021572

Tradename:
CUBICIN
Applicant:
Cubist Pharms Llc
Ingredient:
daptomycin
Patents:7
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 021572

Ingredient-typeLipopeptides

Suppliers and Packaging for NDA: 021572

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CUBICIN
daptomycin
POWDER;INTRAVENOUS 021572 NDA AUTHORIZED GENERIC Teva Parenteral Medicines, Inc. 0703-0125 0703-0125-01 1 VIAL, SINGLE-USE in 1 CARTON (0703-0125-01) > 10 mL in 1 VIAL, SINGLE-USE
CUBICIN
daptomycin
POWDER;INTRAVENOUS 021572 NDA Merck Sharp & Dohme Corp. 67919-011 67919-011-01 1 VIAL, SINGLE-USE in 1 CARTON (67919-011-01) > 10 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;IV (INFUSION)Strength250MG/VIAL
Approval Date:Sep 12, 2003TE:RLD:No
Patent:8,058,238Patent Expiration:Nov 28, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:6,468,967Patent Expiration:Sep 24, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING BACTERIAL INFECTIONS
Patent:6,852,689Patent Expiration:Sep 24, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING BACTERIAL INFECTIONS

Expired Orange Book Patents for NDA: 021572

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;INTRAVENOUS021572-002Sep 12, 20035,912,226► subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;IV (INFUSION)021572-001Sep 12, 20035,912,226► subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;IV (INFUSION)021572-001Sep 12, 2003RE39071► subscribe
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