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 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 |
Formulation / Manufacturing: | see details |
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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