Details for New Drug Application (NDA): 021223
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The generic ingredient in ZOMETA is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Summary for 021223
Tradename: | ZOMETA |
Applicant: | Novartis |
Ingredient: | zoledronic acid |
Patents: | 2 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Aug 20, 2001 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 4MG BASE/5ML | ||||
Approval Date: | Mar 7, 2003 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 29, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 4MG BASE/100ML | ||||
Approval Date: | Jun 17, 2011 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 5, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 021223
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | ZOMETA | zoledronic acid | INJECTABLE;INTRAVENOUS | 021223-001 | Aug 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | ZOMETA | zoledronic acid | INJECTABLE;INTRAVENOUS | 021223-002 | Mar 7, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | ZOMETA | zoledronic acid | INJECTABLE;INTRAVENOUS | 021223-001 | Aug 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | ZOMETA | zoledronic acid | INJECTABLE;INTRAVENOUS | 021223-002 | Mar 7, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | ZOMETA | zoledronic acid | INJECTABLE;INTRAVENOUS | 021223-003 | Jun 17, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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