65219-810-02 |
65219-810 |
HUMAN PRESCRIPTION DRUG |
Xylocaine MPF |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
20201030 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
10 mg/mL |
25 VIAL, SINGLE-DOSE in 1 TRAY (65219-810-02) / 2 mL in 1 VIAL, SINGLE-DOSE (65219-810-01) |
65219-812-02 |
65219-812 |
HUMAN PRESCRIPTION DRUG |
Xylocaine MPF |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
20201030 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
20 mg/mL |
25 VIAL, SINGLE-DOSE in 1 TRAY (65219-812-02) / 2 mL in 1 VIAL, SINGLE-DOSE (65219-812-01) |
65219-814-05 |
65219-814 |
HUMAN PRESCRIPTION DRUG |
Xylocaine MPF |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
20201030 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
20 mg/mL |
25 VIAL, SINGLE-DOSE in 1 TRAY (65219-814-05) / 5 mL in 1 VIAL, SINGLE-DOSE (65219-814-01) |
51662-1405-1 |
51662-1405 |
HUMAN PRESCRIPTION DRUG |
XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE) |
XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE) |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
20191111 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.005 mg/mL; 10 mg/mL |
30 mL in 1 VIAL, SINGLE-DOSE (51662-1405-1) |
51662-1405-3 |
51662-1405 |
HUMAN PRESCRIPTION DRUG |
XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE) |
XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE) |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
20220317 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.005 mg/mL; 10 mg/mL |
25 POUCH in 1 CASE (51662-1405-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1405-2) / 30 mL in 1 VIAL, SINGLE-DOSE |
51662-1412-1 |
51662-1412 |
HUMAN PRESCRIPTION DRUG |
LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE |
LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
20191014 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.005 mg/mL; 20 mg/mL |
10 mL in 1 VIAL, SINGLE-DOSE (51662-1412-1) |
51662-1412-3 |
51662-1412 |
HUMAN PRESCRIPTION DRUG |
LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE |
LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
20220316 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.005 mg/mL; 20 mg/mL |
25 POUCH in 1 BOX (51662-1412-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1412-2) / 10 mL in 1 VIAL, SINGLE-DOSE |
51662-1505-1 |
51662-1505 |
HUMAN PRESCRIPTION DRUG |
LIDOCAINE HCI AND EPINEPHRINE |
LIDOCAINE HCI AND EPINEPHRINE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20200311 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.01 mg/mL; 20 mg/mL |
50 mL in 1 VIAL, MULTI-DOSE (51662-1505-1) |
51662-1505-3 |
51662-1505 |
HUMAN PRESCRIPTION DRUG |
LIDOCAINE HCI AND EPINEPHRINE |
LIDOCAINE HCI AND EPINEPHRINE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20220317 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.01 mg/mL; 20 mg/mL |
25 POUCH in 1 CASE (51662-1505-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1505-2) / 50 mL in 1 VIAL, MULTI-DOSE |
51662-1506-1 |
51662-1506 |
HUMAN PRESCRIPTION DRUG |
LIDOCAINE HCI AND EPINEPHRINE |
LIDOCAINE HCI AND EPINEPHRINE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20200311 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.01 mg/mL; 20 mg/mL |
20 mL in 1 VIAL, MULTI-DOSE (51662-1506-1) |
51662-1506-2 |
51662-1506 |
HUMAN PRESCRIPTION DRUG |
LIDOCAINE HCI AND EPINEPHRINE |
LIDOCAINE HCI AND EPINEPHRINE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20210126 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.01 mg/mL; 20 mg/mL |
1 VIAL, MULTI-DOSE in 1 POUCH (51662-1506-2) / 20 mL in 1 VIAL, MULTI-DOSE |
51662-1506-3 |
51662-1506 |
HUMAN PRESCRIPTION DRUG |
LIDOCAINE HCI AND EPINEPHRINE |
LIDOCAINE HCI AND EPINEPHRINE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20210126 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.01 mg/mL; 20 mg/mL |
25 POUCH in 1 CASE (51662-1506-3) / 1 VIAL, MULTI-DOSE in 1 POUCH / 20 mL in 1 VIAL, MULTI-DOSE |
51662-1550-3 |
51662-1550 |
HUMAN PRESCRIPTION DRUG |
XYLOCAINE-MPF WITH EPI |
XYLOCAINE-MPF WITH EPI |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
20210628 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.005 mg/mL; 20 mg/mL |
25 POUCH in 1 CASE (51662-1550-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1550-2) / 20 mL in 1 VIAL, SINGLE-DOSE |
51662-1587-3 |
51662-1587 |
HUMAN PRESCRIPTION DRUG |
XYLOCAIN (LIDOCAINE HCl ) |
XYLOCAINE (LIDOCAINE HCl ) |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20220615 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
10 mg/mL |
25 POUCH in 1 CASE (51662-1587-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1587-2) / 50 mL in 1 VIAL, MULTI-DOSE (51662-1587-1) |
51662-1604-3 |
51662-1604 |
HUMAN PRESCRIPTION DRUG |
XYLOCAINE- MPF (LIDOCAINE HCl ) |
LIDOCAINE HCl |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
20220915 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
20 mg/mL |
25 POUCH in 1 CASE (51662-1604-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1604-2) / 5 mL in 1 VIAL, SINGLE-DOSE |
51662-1645-3 |
51662-1645 |
HUMAN PRESCRIPTION DRUG |
XYLOCAINE |
XYLOCAINE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20100812 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
10 mg/mL |
25 POUCH in 1 CASE (51662-1645-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1645-2) / 20 mL in 1 VIAL, MULTI-DOSE |
63323-481-57 |
63323-481 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20100812 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.005 mg/mL; 5 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (63323-481-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-481-01) |
63323-482-26 |
63323-482 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20100812 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.01 mg/mL; 10 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (63323-482-26) / 20 mL in 1 VIAL, MULTI-DOSE (63323-482-41) |
63323-482-17 |
63323-482 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20100812 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.01 mg/mL; 10 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (63323-482-17) / 10 mL in 1 VIAL, MULTI-DOSE (63323-482-01) |
63323-482-27 |
63323-482 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20100812 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.01 mg/mL; 10 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (63323-482-27) / 20 mL in 1 VIAL, MULTI-DOSE (63323-482-03) |