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Generated: August 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078218

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NDA 078218 describes CYCLOBENZAPRINE HYDROCHLORIDE, which is a drug marketed by Oxford Pharms, Actavis Labs Fl Inc, Orit Labs Llc, Pliva, Sun Pharm Inds Ltd, Watson Labs, Frontida Biopharm, Aurobindo Pharma, Mylan Pharms Inc, Kvk Tech, Upsher-smith Labs, Jubilant Cadista, Rubicon Res Pvt Ltd, Invagen Pharms, Twi Pharms Inc, Sandoz, and Prinston Inc, and is included in eighteen NDAs. It is available from seventy-four suppliers. Additional details are available on the CYCLOBENZAPRINE HYDROCHLORIDE profile page.

The generic ingredient in CYCLOBENZAPRINE HYDROCHLORIDE is cyclobenzaprine hydrochloride. There are fifteen drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.

Summary for NDA: 078218

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details

Pharmacology for NDA: 078218

Suppliers and Packaging for NDA: 078218

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOBENZAPRINE HYDROCHLORIDE
cyclobenzaprine hydrochloride
TABLET;ORAL 078218 ANDA Blenheim Pharmacal, Inc. 10544-159 10544-159-09 9 TABLET in 1 BOTTLE (10544-159-09)
CYCLOBENZAPRINE HYDROCHLORIDE
cyclobenzaprine hydrochloride
TABLET;ORAL 078218 ANDA Blenheim Pharmacal, Inc. 10544-159 10544-159-15 15 TABLET in 1 BOTTLE (10544-159-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 18, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 19, 2015TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
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Novartis
Daiichi Sankyo
Covington
Express Scripts
Farmers Insurance
US Department of Justice
AstraZeneca
Citi

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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