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Details for New Drug Application (NDA): 021208

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

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

Summary for NDA: 021208

Tradename:
REMERON SOLTAB
Applicant:
Organon Usa Inc
Ingredient:
mirtazapine
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

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 USA Inc. 0052-0106 0052-0106-30 5 BLISTER PACK in 1 BOX (0052-0106-30) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0052-0106-06)
REMERON SOLTAB
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL 021208 NDA Organon USA Inc. 0052-0108 0052-0108-30 5 BLISTER PACK in 1 BOX (0052-0108-30) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0052-0108-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength15MG
Approval Date:Jan 12, 2001TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength30MG
Approval Date:Jan 12, 2001TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength45MG
Approval Date:Jan 12, 2001TE:ABRLD:No

Expired Orange Book Patents for NDA: 021208

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc
REMERON SOLTAB
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL021208-001Jan 12, 20015,178,878► subscribe
Organon Usa Inc
REMERON SOLTAB
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL021208-003Jan 12, 20015,178,878► subscribe
Organon Usa Inc
REMERON SOLTAB
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL021208-002Jan 12, 20015,178,878► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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