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Details for New Drug Application (NDA): 020907

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NDA 020907 describes ACTIVELLA, which is a drug marketed by Amneal Pharms Llc and is included in one NDA. It is available from three suppliers. Additional details are available on the ACTIVELLA profile page.

The generic ingredient in ACTIVELLA is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.

Summary for NDA: 020907

Tradename:
ACTIVELLA
Applicant:
Amneal Pharms Llc
Ingredient:
estradiol; norethindrone acetate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020907

Suppliers and Packaging for NDA: 020907

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACTIVELLA
estradiol; norethindrone acetate
TABLET;ORAL 020907 NDA Novo Nordisk 0169-5174 0169-5174-01 5 CARTON in 1 CELLO PACK (0169-5174-01) > 1 DIALPACK in 1 CARTON > 28 TABLET, FILM COATED in 1 DIALPACK
ACTIVELLA
estradiol; norethindrone acetate
TABLET;ORAL 020907 NDA Novo Nordisk 0169-5174 0169-5174-02 1 DIALPACK in 1 CARTON (0169-5174-02) > 28 TABLET, FILM COATED in 1 DIALPACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG;0.5MG
Approval Date:Nov 18, 1998TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG;0.1MG
Approval Date:Dec 28, 2006TE:ABRLD:No

Expired Orange Book Patents for NDA: 020907

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amneal Pharms Llc
ACTIVELLA
estradiol; norethindrone acetate
TABLET;ORAL020907-001Nov 18, 1998RE36247► 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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