← FDA Drug Approvals (Drugs@FDA)

BUPIVACAINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ONESOURCE SPECIALTY · Approved 2011-10-18

Drug application

FDA Application #
ANDA091503
Application type
Abbreviated New Drug Application (Generic)
Brand name
BUPIVACAINE HYDROCHLORIDE
Generic name
BUPIVACAINE HYDROCHLORIDE
Active ingredients
BUPIVACAINE HYDROCHLORIDE
Dosage form
INJECTABLE
Route
INJECTION
Marketing status
Prescription
Sponsor
ONESOURCE SPECIALTY
Manufacturer
Xellia Pharmaceuticals USA LLC
First approval
2011-10-18

Source

Authoritative
Drugs@FDA application overview
Machine
JSON-LD · Markdown