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Last Updated: December 6, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020064


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NDA 020064 describes MACROBID, which is a drug marketed by Almatica and is included in one NDA. It is available from fifteen 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. Twenty-six suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 020064
Tradename:MACROBID
Applicant:Almatica
Ingredient:nitrofurantoin; nitrofurantoin, macrocrystalline
Patents:0
Pharmacology for NDA: 020064
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 PD-Rx Pharmaceuticals, Inc. 43063-582 43063-582-10 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-582-10)
MACROBID nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 020064 NDA PD-Rx Pharmaceuticals, Inc. 43063-582 43063-582-14 14 CAPSULE in 1 BOTTLE, PLASTIC (43063-582-14)
Paragraph IV (Patent) Challenges for 020064
Tradename Dosage Ingredient NDA Submissiondate
MACROBID CAPSULE;ORAL nitrofurantoin; nitrofurantoin, macrocrystalline 020064

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
Almatica MACROBID nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 020064-001 Dec 24, 1991 ⤷  Free Forever Trial ⤷  Free Forever Trial
Almatica MACROBID nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 020064-001 Dec 24, 1991 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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