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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 four suppliers. There are seven 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 fifty-four drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.

Summary for NDA: 020835

Tradename:
ACTONEL
Applicant:
Apil
Ingredient:
risedronate sodium
Patents:7
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020835

Ingredient-typeDiphosphonates

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 Warner Chilcott Pharmaceuticals Inc. 0149-0470 0149-0470-01 12 BOTTLE in 1 CASE (0149-0470-01) > 30 TABLET, FILM COATED in 1 BOTTLE
ACTONEL
risedronate sodium
TABLET;ORAL 020835 NDA Warner Chilcott Pharmaceuticals Inc. 0149-0471 0149-0471-01 12 BOTTLE in 1 CASE (0149-0471-01) > 30 TABLET, FILM COATED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Mar 27, 1998TE:ABRLD:No
Patent:6,165,513*PEDPatent Expiration:Dec 10, 2018Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 14, 2000TE:ABRLD:No
Patent:6,165,513*PEDPatent Expiration:Dec 10, 2018Product Flag?Substance Flag?Delist Request?Y

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength35MG
Approval Date:May 25, 2002TE:ABRLD:Yes
Patent:5,994,329*PEDPatent Expiration:Jan 17, 2019Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020835

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-002Apr 14, 20005,583,122*PED► subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-005Apr 22, 20085,583,122*PED► subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-001Mar 27, 19986,096,342*PED► subscribe
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