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Last Updated: March 29, 2024

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 two suppliers. 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:0
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. 0430-0472 0430-0472-03 4 TABLET, FILM COATED in 1 DOSE PACK (0430-0472-03)
ACTONEL risedronate sodium TABLET;ORAL 020835 NDA Allergan, Inc. 0430-0472 0430-0472-07 12 TABLET, FILM COATED in 1 DOSE PACK (0430-0472-07)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength35MG
Approval Date:May 25, 2002TE:ABRLD:Yes

Expired US Patents for NDA 020835

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-005 Apr 22, 2008 ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-005 Apr 22, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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