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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078470

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NDA 078470 describes ACARBOSE, which is a drug marketed by Emcure Pharms Ltd, Impax Labs, Mylan, Strides Pharma, Virtus Pharm, Watson Labs, and West-ward Pharms Int, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the ACARBOSE profile page.

The generic ingredient in ACARBOSE is acarbose. There are six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the acarbose profile page.

Summary for 078470

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 078470

Mechanism of Actionalpha Glucosidase Inhibitors

Medical Subject Heading (MeSH) Categories for 078470

Suppliers and Packaging for NDA: 078470

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACARBOSE acarbose TABLET;ORAL 078470 ANDA West-Ward Pharmaceuticals Corp 0054-0140 0054-0140-25 100 TABLET in 1 BOTTLE (0054-0140-25)
ACARBOSE acarbose TABLET;ORAL 078470 ANDA West-Ward Pharmaceuticals Corp 0054-0141 0054-0141-20 10 BLISTER PACK in 1 CARTON (0054-0141-20) > 10 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 7, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 7, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:May 7, 2008TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Covington
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Moodys
Dow
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McKesson

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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