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Generated: July 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077246

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NDA 077246 describes DANAZOL, which is a drug marketed by Lannett, Am Therap, and Barr, and is included in three NDAs. It is available from four suppliers. Additional details are available on the DANAZOL profile page.

The generic ingredient in DANAZOL is danazol. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the danazol profile page.

Summary for NDA: 077246

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 077246

Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists

Suppliers and Packaging for NDA: 077246

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DANAZOL
danazol
CAPSULE;ORAL 077246 ANDA Lannett Company, Inc. 0527-1369 0527-1369-01 100 CAPSULE in 1 BOTTLE (0527-1369-01)
DANAZOL
danazol
CAPSULE;ORAL 077246 ANDA Lannett Company, Inc. 0527-1369 0527-1369-06 60 CAPSULE in 1 BOTTLE (0527-1369-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Sep 28, 2005TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Apr 19, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Apr 19, 2007TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Healthtrust
Teva
Chinese Patent Office
Johnson and Johnson
Cipla
Daiichi Sankyo
Colorcon
UBS
Mallinckrodt

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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