Details for New Drug Application (NDA): 020997
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The generic ingredient in CHIROCAINE is levobupivacaine hydrochloride. There is one drug master file entry for this compound. Additional details are available on the levobupivacaine hydrochloride profile page.
Summary for 020997
| Tradename: | CHIROCAINE |
| Applicant: | Purdue Pharma Lp |
| Ingredient: | levobupivacaine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 5, 1999 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 5, 1999 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 7.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 5, 1999 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020997
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Purdue Pharma Lp | CHIROCAINE | levobupivacaine hydrochloride | INJECTABLE;INJECTION | 020997-001 | Aug 5, 1999 | ⤷ Start Trial | ⤷ Start Trial |
| Purdue Pharma Lp | CHIROCAINE | levobupivacaine hydrochloride | INJECTABLE;INJECTION | 020997-003 | Aug 5, 1999 | ⤷ Start Trial | ⤷ Start Trial |
| Purdue Pharma Lp | CHIROCAINE | levobupivacaine hydrochloride | INJECTABLE;INJECTION | 020997-002 | Aug 5, 1999 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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