Details for New Drug Application (NDA): 204842
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NDA 204842 describes BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Eugia Pharma, Hikma Pharms, Intl Medicated, and Steriscience Speclts, and is included in four NDAs. It is available from five suppliers. Additional details are available on the BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE profile page.
The generic ingredient in BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE is bupivacaine hydrochloride. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.
The generic ingredient in BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE is bupivacaine hydrochloride. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.
Summary for 204842
| Tradename: | BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE |
| Applicant: | Hikma Pharms |
| Ingredient: | bupivacaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204842
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 204842
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 204842 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9330 | 0143-9330-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9330-10) / 10 mL in 1 VIAL, SINGLE-DOSE (0143-9330-01) |
| BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 204842 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9331 | 0143-9331-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9331-10) / 10 mL in 1 VIAL, SINGLE-DOSE (0143-9331-01) |
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 | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.75% | ||||
| Approval Date: | Feb 11, 2021 | TE: | AP | RLD: | No | ||||
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