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Details for New Drug Application (NDA): 021506

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NDA 021506 describes MYCAMINE, which is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MYCAMINE profile page.

The generic ingredient in MYCAMINE is micafungin sodium. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the micafungin sodium profile page.

Summary for NDA: 021506

Tradename:
MYCAMINE
Applicant:
Astellas
Ingredient:
micafungin sodium
Patents:3
Therapeutic Class:Antifungals

Pharmacology for NDA: 021506

Ingredient-typeLipopeptides

Suppliers and Packaging for NDA: 021506

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCAMINE
micafungin sodium
INJECTABLE;IV (INFUSION) 021506 NDA Astellas Pharma US, Inc. 0469-3211 0469-3211-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3211-10) > 10 mL in 1 VIAL, SINGLE-DOSE
MYCAMINE
micafungin sodium
INJECTABLE;IV (INFUSION) 021506 NDA Astellas Pharma US, Inc. 0469-3211 0469-3211-99 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3211-99) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 50MG BASE/VIAL
Approval Date:Mar 16, 2005TE:RLD:Yes
Patent:6,107,458Patent Expiration:Mar 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ESOPHAGEAL CANDIDIASIS AND PROPHYLAXIS OF CANDIDA INFECTIONS IN HSCT PATIENTS
Patent:6,265,536Patent Expiration:Sep 29, 2015Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ESOPHAGEAL CANDIDIASIS AND PROPHYLAXIS OF CANDIDA INFECTIONS IN HSCT PATIENTS
Patent:6,774,104Patent Expiration:Jan 8, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ESOPHAGEAL CANDIDIASIS AND PROPHYLAXIS OF CANDIDA INFECTIONS IN HSCT PATIENTS

Expired Orange Book Patents for NDA: 021506

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas
MYCAMINE
micafungin sodium
INJECTABLE;IV (INFUSION)021506-002Mar 16, 20055,376,634► subscribe
Astellas
MYCAMINE
micafungin sodium
INJECTABLE;IV (INFUSION)021506-003Jun 27, 20065,376,634► subscribe
Astellas
MYCAMINE
micafungin sodium
INJECTABLE;IV (INFUSION)021506-003Jun 27, 20066,265,536► subscribe
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