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Details for New Drug Application (NDA): 203565

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NDA 203565 describes INJECTAFER, which is a drug marketed by Luitpold Pharms Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the INJECTAFER profile page.

The generic ingredient in INJECTAFER is ferric carboxymaltose. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric carboxymaltose profile page.

Summary for NDA: 203565

Tradename:
INJECTAFER
Applicant:
Luitpold Pharms Inc
Ingredient:
ferric carboxymaltose
Patents:4

Pharmacology for NDA: 203565

Ingredient-typeIron
Mechanism of ActionPhosphate Chelating Activity

Suppliers and Packaging for NDA: 203565

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTAFER
ferric carboxymaltose
INJECTABLE;INTRAVENOUS 203565 NDA American Regent, Inc. 0517-0650 0517-0650-01 1 VIAL, SINGLE-DOSE in 1 BOX (0517-0650-01) > 15 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength750MG IRON/15ML (50MG IRON/ML)
Approval Date:Jul 25, 2013TE:RLD:Yes
Patent:7,612,109Patent Expiration:Feb 5, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:9,376,505Patent Expiration:Oct 20, 2023Product Flag?YSubstance Flag?YDelist Request?
Patent:7,754,702Patent Expiration:Feb 13, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX


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