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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Fish and Richardson
Deloitte
Cipla
Federal Trade Commission
Farmers Insurance
Healthtrust
Johnson and Johnson
Teva

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020064

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NDA 020064 describes MACROBID, which is a drug marketed by Alvogen Malta and is included in one NDA. It is available from twenty suppliers. Additional details are available on the MACROBID profile page.

The generic ingredient in MACROBID is nitrofurantoin; nitrofurantoin, macrocrystalline. There are twenty drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 020064
Tradename:MACROBID
Applicant:Alvogen Malta
Ingredient:nitrofurantoin; nitrofurantoin, macrocrystalline
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020064
Ingredient-typeNitrofurans
Suppliers and Packaging for NDA: 020064
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MACROBID nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 020064 NDA Aidarex Pharmaceuticals LLC 33261-160 N 33261-160-10
MACROBID nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 020064 NDA Aidarex Pharmaceuticals LLC 33261-160 N 33261-160-14

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG;25MG
Approval Date:Dec 24, 1991TE:ABRLD:Yes

Expired US Patents for NDA 020064

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen Malta MACROBID nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 020064-001 Dec 24, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
Alvogen Malta MACROBID nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 020064-001 Dec 24, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Mallinckrodt
Cipla
Farmers Insurance
McKinsey
Medtronic
Deloitte
Cantor Fitzgerald
Baxter

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