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Generated: November 12, 2018

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Details for New Drug Application (NDA): 021642

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NDA 021642 describes NASCOBAL, which is a drug marketed by Par Pharm and Endo Pharms Inc and is included in two NDAs. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NASCOBAL profile page.

The generic ingredient in NASCOBAL is cyanocobalamin. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.
Summary for 021642
Tradename:NASCOBAL
Applicant:Endo Pharms Inc
Ingredient:cyanocobalamin
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 021642
Ingredient-typeVitamin B 12
Suppliers and Packaging for NDA: 021642
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642 NDA Par Pharmaceutical , Inc 49884-270 49884-270-82 4 SPRAY in 1 CARTON (49884-270-82)
NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642 NDA Par Pharmaceutical , Inc 49884-270 49884-270-86 4 SPRAY in 1 BOTTLE (49884-270-86)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.5MG/SPRAY
Approval Date:Jan 31, 2005TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 1, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:NASAL ADMINISTRATION OF CYANOCOBALAMIN
Patent:➤ Sign UpPatent Expiration:Mar 12, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Aug 1, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:CYANOCOBALAMIN ADMINISTRATION THROUGH NASAL INFUSION

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