Details for New Drug Application (NDA): 202344
✉ Email this page to a colleague
The generic ingredient in BINOSTO is alendronate sodium. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.
Summary for 202344
| Tradename: | BINOSTO |
| Applicant: | Radius |
| Ingredient: | alendronate sodium |
| Patents: | 1 |
Suppliers and Packaging for NDA: 202344
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BINOSTO | alendronate sodium | TABLET, EFFERVESCENT;ORAL | 202344 | NDA | Radius Health, Inc. | 70539-400 | 70539-400-04 | 4 BLISTER PACK in 1 BOX (70539-400-04) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00) |
| BINOSTO | alendronate sodium | TABLET, EFFERVESCENT;ORAL | 202344 | NDA | Radius Health, Inc. | 70539-400 | 70539-400-94 | 4 BLISTER PACK in 1 BOX (70539-400-94) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EFFERVESCENT;ORAL | Strength | EQ 70MG BASE | ||||
| Approval Date: | Mar 12, 2012 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 5, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 202344
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Radius | BINOSTO | alendronate sodium | TABLET, EFFERVESCENT;ORAL | 202344-001 | Mar 12, 2012 | ⤷ Start Trial | ⤷ Start Trial |
| Radius | BINOSTO | alendronate sodium | TABLET, EFFERVESCENT;ORAL | 202344-001 | Mar 12, 2012 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
