Details for New Drug Application (NDA): 216040
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NDA 216040 describes BUPIVACAINE HYDROCHLORIDE, which is a drug marketed by Aspiro, Civica, Eugia Pharma, Hikma Pharms, Hospira, Meitheal, Onesource Specialty, Somerset, B Braun Medical, Baxter Hlthcare Corp, Huons, and Intl Medicated, and is included in thirty-four NDAs. It is available from twenty-one suppliers. Additional details are available on the BUPIVACAINE HYDROCHLORIDE profile page.
The generic ingredient in BUPIVACAINE HYDROCHLORIDE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
The generic ingredient in BUPIVACAINE HYDROCHLORIDE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
Summary for 216040
| Tradename: | BUPIVACAINE HYDROCHLORIDE |
| Applicant: | Meitheal |
| Ingredient: | bupivacaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216040
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 216040
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 216040 | ANDA | Meitheal Pharmaceuticals Inc | 71288-721 | 71288-721-11 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-721-11) / 10 mL in 1 VIAL, SINGLE-DOSE |
| BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 216040 | ANDA | Meitheal Pharmaceuticals Inc | 71288-722 | 71288-722-32 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-722-32) / 30 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25% | ||||
| Approval Date: | Dec 27, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5% | ||||
| Approval Date: | Dec 27, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.75% | ||||
| Approval Date: | Dec 27, 2023 | TE: | AP | RLD: | No | ||||
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