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Last Updated: January 20, 2020

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Details for New Drug Application (NDA): 020835

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NDA 020835 describes ACTONEL, which is a drug marketed by Apil and Warner Chilcott and is included in two NDAs. It is available from three suppliers. There are six patents protecting this drug and four Paragraph IV challenges. Additional details are available on the ACTONEL profile page.

The generic ingredient in ACTONEL is calcium carbonate; risedronate sodium. There are two hundred and eighty-two drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.
Summary for 020835
Tradename:ACTONEL
Applicant:Apil
Ingredient:risedronate sodium
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 020835
Medical Subject Heading (MeSH) Categories for 020835
Suppliers and Packaging for NDA: 020835
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACTONEL risedronate sodium TABLET;ORAL 020835 NDA Allergan, Inc. 0430-0470 0430-0470-15 30 TABLET, FILM COATED in 1 BOTTLE (0430-0470-15)
ACTONEL risedronate sodium TABLET;ORAL 020835 NDA Allergan, Inc. 0430-0471 0430-0471-15 30 TABLET, FILM COATED in 1 BOTTLE (0430-0471-15)
Paragraph IV (Patent) Challenges for 020835
Tradename Dosage Ingredient NDA Submissiondate
ACTONEL TABLET;ORAL risedronate sodium 020835 2008-08-12
ACTONEL TABLET;ORAL risedronate sodium 020835 2007-09-10
ACTONEL TABLET;ORAL risedronate sodium 020835 2004-04-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Mar 27, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 14, 2000TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength35MG
Approval Date:May 25, 2002TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jan 17, 2019Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 020835

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007   Start Trial   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002   Start Trial   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002   Start Trial   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998   Start Trial   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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