Details for New Drug Application (NDA): 203895
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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. Twenty-one suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.
Summary for 203895
Tradename: | BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE |
Applicant: | Eugia Pharma |
Ingredient: | bupivacaine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 203895
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 203895
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 203895 | ANDA | Eugia US LLC | 55150-167 | 55150-167-10 | 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-167-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 203895 | ANDA | Eugia US LLC | 55150-168 | 55150-168-30 | 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-168-30) / 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: | Nov 5, 2013 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5% | ||||
Approval Date: | Nov 5, 2013 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.75% | ||||
Approval Date: | Nov 5, 2013 | TE: | AP | RLD: | No |
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