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Generated: May 24, 2017

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Details for New Drug Application (NDA): 021073

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NDA 021073 describes ACTOS, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from eleven suppliers. There is one patent protecting this drug. Additional details are available on the ACTOS profile page.

The generic ingredient in ACTOS is pioglitazone hydrochloride. There are twenty-seven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the pioglitazone hydrochloride profile page.

Summary for NDA: 021073

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

Pharmacology for NDA: 021073

Suppliers and Packaging for NDA: 021073

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACTOS
pioglitazone hydrochloride
TABLET;ORAL 021073 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA Inc 0093-2046 0093-2046-05 500 TABLET in 1 BOTTLE (0093-2046-05)
ACTOS
pioglitazone hydrochloride
TABLET;ORAL 021073 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA Inc 0093-2046 0093-2046-56 30 TABLET in 1 BOTTLE (0093-2046-56)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Jul 15, 1999TE:ABRLD:Yes
Patent:6,303,640Patent Expiration:Aug 9, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMIN TO A DIABETIC BY ADMIN A CHEMICAL COMPOUND HAVING FORMULA (INCL PIOGLITAZONE) IN COMBINATION WITH AN INSULIN SECRETION ENHANCER

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Jul 15, 1999TE:ABRLD:Yes
Patent:6,303,640Patent Expiration:Aug 9, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMIN TO A DIABETIC BY ADMIN A CHEMICAL COMPOUND HAVING FORMULA (INCL PIOGLITAZONE) IN COMBINATION WITH AN INSULIN SECRETION ENHANCER

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 45MG BASE
Approval Date:Jul 15, 1999TE:ABRLD:Yes
Patent:6,303,640Patent Expiration:Aug 9, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMIN TO A DIABETIC BY ADMIN A CHEMICAL COMPOUND HAVING FORMULA (INCL PIOGLITAZONE) IN COMBINATION WITH AN INSULIN SECRETION ENHANCER

Expired Orange Book Patents for NDA: 021073

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-003Jul 15, 19996,211,205► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-002Jul 15, 19996,303,640► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-001Jul 15, 19996,166,043► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-001Jul 15, 19995,965,584► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-003Jul 15, 19996,166,042► 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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