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 ten 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-five 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	Major Pharmaceuticals	0904-7137	0904-7137-61	100 BLISTER PACK in 1 CARTON (0904-7137-61) / 1 CAPSULE in 1 BLISTER PACK
MACROBID	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	020064	NDA	Alvogen Inc.	47781-303	47781-303-01	100 CAPSULE in 1 BOTTLE (47781-303-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	75MG;25MG
Approval Date:	Dec 24, 1991	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020064

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

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