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Last Updated: March 26, 2023

Details for New Drug Application (NDA): 016620

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NDA 016620 describes MACRODANTIN, which is a drug marketed by Almatica and is included in one NDA. It is available from nine suppliers. Additional details are available on the MACRODANTIN profile page.

The generic ingredient in MACRODANTIN is nitrofurantoin, macrocrystalline. Twenty-six suppliers are listed for this compound. Additional details are available on the nitrofurantoin, macrocrystalline profile page.

Summary for 016620

Tradename:	MACRODANTIN
Applicant:	Almatica
Ingredient:	nitrofurantoin, macrocrystalline
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 016620

Suppliers and Packaging for NDA: 016620

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MACRODANTIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	016620	NDA	Major Pharmaceuticals	0904-7136	0904-7136-61	100 BLISTER PACK in 1 CARTON (0904-7136-61) / 1 CAPSULE in 1 BLISTER PACK
MACRODANTIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	016620	NDA	PD-Rx Pharmaceuticals, Inc.	43063-400	43063-400-14	14 CAPSULE in 1 BOTTLE, PLASTIC (43063-400-14)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

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