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Serving 500+ biopharmaceutical companies globally:

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Generated: July 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078292

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NDA 078292 describes DRONABINOL, which is a drug marketed by Insys Therap, Akorn Inc, and Svc Pharma, and is included in three NDAs. It is available from five suppliers. Additional details are available on the DRONABINOL profile page.

The generic ingredient in DRONABINOL is dronabinol. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dronabinol profile page.

Summary for NDA: 078292

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 078292

Ingredient-typeCannabinoids

Suppliers and Packaging for NDA: 078292

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DRONABINOL
dronabinol
CAPSULE;ORAL 078292 ANDA Par Pharmaceutical Inc. 49884-867 49884-867-01 100 CAPSULE in 1 BOTTLE (49884-867-01)
DRONABINOL
dronabinol
CAPSULE;ORAL 078292 ANDA Par Pharmaceutical Inc. 49884-867 49884-867-02 60 CAPSULE in 1 BOTTLE (49884-867-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Jun 27, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jun 27, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Jun 27, 2008TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

UBS
Citi
QuintilesIMS
Novartis
Cipla
Fuji
Johnson and Johnson
Cerilliant
Medtronic
AstraZeneca

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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