Details for New Drug Application (NDA): 021208

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NDA 021208 describes REMERON SOLTAB, which is a drug marketed by Organon Usa Organon and is included in one NDA. It is available from one supplier. Additional details are available on the REMERON SOLTAB profile page.

The generic ingredient in REMERON SOLTAB is mirtazapine. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.

Summary for 021208

Tradename:	REMERON SOLTAB
Applicant:	Organon Usa Organon
Ingredient:	mirtazapine
Patents:	0

Suppliers and Packaging for NDA: 021208

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208	NDA	Organon LLC	78206-156	78206-156-01	5 BLISTER PACK in 1 BOX (78206-156-01) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (78206-156-99)
REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208	NDA	Organon LLC	78206-158	78206-158-01	5 BLISTER PACK in 1 BOX (78206-158-01) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (78206-158-99)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	15MG
Approval Date:	Jan 12, 2001	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	30MG
Approval Date:	Jan 12, 2001	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	45MG
Approval Date:	Jan 12, 2001	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021208

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-003	Jan 12, 2001	⤷ Subscribe	⤷ Subscribe
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-001	Jan 12, 2001	⤷ Subscribe	⤷ Subscribe
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-003	Jan 12, 2001	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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