Details for New Drug Application (NDA): 204842
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The generic ingredient in BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE is bupivacaine hydrochloride. There are twelve drug master file entries for this compound. Nineteen 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 |
Formulation / Manufacturing: | see details |
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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