Details for New Drug Application (NDA): 205141
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NDA 205141 describes BUPIVACAINE HYDROCHLORIDE, which is a drug marketed by Aspiro, Civica, Eugia Pharma, Hikma Pharms, Hospira, Meitheal, Somerset, Steriscience Speclts, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, and Intl Medicated, and is included in thirty-four NDAs. It is available from eighteen 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 205141
| Tradename: | BUPIVACAINE HYDROCHLORIDE |
| Applicant: | Hikma Pharms |
| Ingredient: | bupivacaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 205141
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 205141
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 205141 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9328 | 0143-9328-10 | 10 VIAL, MULTI-DOSE in 1 CARTON (0143-9328-10) / 50 mL in 1 VIAL, MULTI-DOSE (0143-9328-01) |
| BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 205141 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9329 | 0143-9329-10 | 10 VIAL, MULTI-DOSE in 1 CARTON (0143-9329-10) / 50 mL in 1 VIAL, MULTI-DOSE (0143-9329-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25% | ||||
| Approval Date: | Feb 11, 2021 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5% | ||||
| Approval Date: | Feb 11, 2021 | TE: | AP | RLD: | No | ||||
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