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Details for New Drug Application (NDA): 021823
The generic ingredient in ACTONEL WITH CALCIUM (COPACKAGED) is calcium carbonate; risedronate sodium. There are two hundred and seventy-five drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.
Summary for 021823
Tradename: | ACTONEL WITH CALCIUM (COPACKAGED) |
Applicant: | Warner Chilcott |
Ingredient: | calcium carbonate; risedronate sodium |
Patents: | 5 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, TABLET;ORAL | Strength | EQ 500MG BASE,N/A;N/A,35MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
Approval Date: | Aug 12, 2005 | TE: | RLD: | Yes | |||||
Patent: | ➤ Try a Free Trial | Patent Expiration: | Jan 17, 2019 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ➤ Try a Free Trial | Patent Expiration: | Jan 17, 2019 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ➤ Try a Free Trial | Patent Expiration: | Dec 10, 2018 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 021823
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Warner Chilcott | ACTONEL WITH CALCIUM (COPACKAGED) | calcium carbonate; risedronate sodium | TABLET, TABLET;ORAL | 021823-001 | Aug 12, 2005 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Warner Chilcott | ACTONEL WITH CALCIUM (COPACKAGED) | calcium carbonate; risedronate sodium | TABLET, TABLET;ORAL | 021823-001 | Aug 12, 2005 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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