| 70594-114-02 |
70594-114 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine HCl |
Bupivacaine hydrochloride |
INJECTION, SOLUTION |
EPIDURAL; INTRACAUDAL; PERINEURAL |
20230601 |
N/A |
ANDA |
ANDA091487 |
Xellia Pharmaceuticals USA LLC |
BUPIVACAINE HYDROCHLORIDE |
2.5 mg/mL |
10 VIAL in 1 CARTON (70594-114-02) / 10 mL in 1 VIAL (70594-114-01) |
| 70594-115-01 |
70594-115 |
HUMAN PRESCRIPTION DRUG |
BUPIVACAINE HCl |
Bupivacaine hydrochloride |
INJECTION, SOLUTION |
EPIDURAL; INTRACAUDAL; PERINEURAL |
20230601 |
N/A |
ANDA |
ANDA091487 |
Xellia Pharmaceuticals USA LLC |
BUPIVACAINE HYDROCHLORIDE |
2.5 mg/mL |
30 mL in 1 VIAL, SINGLE-DOSE (70594-115-01) |
| 70594-117-02 |
70594-117 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine HCl |
Bupivacaine hydrochloride |
INJECTION, SOLUTION |
EPIDURAL; INTRACAUDAL; PERINEURAL |
20230601 |
N/A |
ANDA |
ANDA091487 |
Xellia Pharmaceuticals USA LLC |
BUPIVACAINE HYDROCHLORIDE |
5 mg/mL |
10 VIAL in 1 CARTON (70594-117-02) / 10 mL in 1 VIAL (70594-117-01) |
| 70594-118-01 |
70594-118 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine HCl |
Bupivacaine hydrochloride |
INJECTION, SOLUTION |
EPIDURAL; INTRACAUDAL; PERINEURAL |
20230601 |
N/A |
ANDA |
ANDA091487 |
Xellia Pharmaceuticals USA LLC |
BUPIVACAINE HYDROCHLORIDE |
5 mg/mL |
30 mL in 1 VIAL, SINGLE-DOSE (70594-118-01) |
| 70594-120-02 |
70594-120 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine HCl |
Bupivacaine hydrochloride |
INJECTION, SOLUTION |
EPIDURAL; INTRACAUDAL; PERINEURAL |
20230601 |
N/A |
ANDA |
ANDA091487 |
Xellia Pharmaceuticals USA LLC |
BUPIVACAINE HYDROCHLORIDE |
7.5 mg/mL |
10 VIAL in 1 CARTON (70594-120-02) / 10 mL in 1 VIAL (70594-120-01) |
| 70594-121-01 |
70594-121 |
HUMAN PRESCRIPTION DRUG |
Bupivacine HCl |
Bupivacaine hydrochloride |
INJECTION, SOLUTION |
EPIDURAL; INTRACAUDAL; PERINEURAL |
20230601 |
N/A |
ANDA |
ANDA091487 |
Xellia Pharmaceuticals USA LLC |
BUPIVACAINE HYDROCHLORIDE |
7.5 mg/mL |
30 mL in 1 VIAL, SINGLE-DOSE (70594-121-01) |
| 83270-162-10 |
83270-162 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine Hydrochloride |
Bupivacaine Hydrochloride |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION |
20260129 |
N/A |
ANDA |
ANDA091487 |
ONESOURCE SPECIALTY PHARMA LIMITED |
BUPIVACAINE HYDROCHLORIDE |
2.5 mg/mL |
10 VIAL in 1 CARTON (83270-162-10) / 10 mL in 1 VIAL |
| 83270-163-10 |
83270-163 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine Hydrochloride |
Bupivacaine Hydrochloride |
INJECTION, SOLUTION |
EPIDURAL |
20260129 |
N/A |
ANDA |
ANDA091487 |
ONESOURCE SPECIALTY PHARMA LIMITED |
BUPIVACAINE HYDROCHLORIDE |
5 mg/mL |
10 VIAL in 1 CARTON (83270-163-10) / 10 mL in 1 VIAL |
| 83270-164-10 |
83270-164 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine Hydrochloride |
Bupivacaine Hydrochloride |
INJECTION, SOLUTION |
EPIDURAL; RETROBULBAR |
20260129 |
N/A |
ANDA |
ANDA091487 |
ONESOURCE SPECIALTY PHARMA LIMITED |
BUPIVACAINE HYDROCHLORIDE |
7.5 mg/mL |
10 VIAL in 1 CARTON (83270-164-10) / 10 mL in 1 VIAL |
| 83270-165-01 |
83270-165 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine Hydrochloride |
Bupivacaine Hydrochloride |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION |
20260129 |
N/A |
ANDA |
ANDA091487 |
ONESOURCE SPECIALTY PHARMA LIMITED |
BUPIVACAINE HYDROCHLORIDE |
2.5 mg/mL |
1 VIAL in 1 CARTON (83270-165-01) / 30 mL in 1 VIAL |
| 83270-166-01 |
83270-166 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine Hydrochloride |
Bupivacaine Hydrochloride |
INJECTION, SOLUTION |
EPIDURAL |
20260129 |
N/A |
ANDA |
ANDA091487 |
ONESOURCE SPECIALTY PHARMA LIMITED |
BUPIVACAINE HYDROCHLORIDE |
5 mg/mL |
1 VIAL in 1 CARTON (83270-166-01) / 30 mL in 1 VIAL |
| 83270-167-01 |
83270-167 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine Hydrochloride |
Bupivacaine Hydrochloride |
INJECTION, SOLUTION |
EPIDURAL; RETROBULBAR |
20260129 |
N/A |
ANDA |
ANDA091487 |
ONESOURCE SPECIALTY PHARMA LIMITED |
BUPIVACAINE HYDROCHLORIDE |
7.5 mg/mL |
1 VIAL in 1 CARTON (83270-167-01) / 30 mL in 1 VIAL |
| 72266-264-10 |
72266-264 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine Hydrochloride |
Bupivacaine Hydrochloride |
INJECTION, SOLUTION |
EPIDURAL |
20251208 |
N/A |
ANDA |
ANDA091487 |
Fosun Pharma USA Inc. |
BUPIVACAINE HYDROCHLORIDE |
5 mg/mL |
10 VIAL in 1 CARTON (72266-264-10) / 10 mL in 1 VIAL |
| 72266-263-10 |
72266-263 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine Hydrochloride |
Bupivacaine Hydrochloride |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION |
20251208 |
N/A |
ANDA |
ANDA091487 |
Fosun Pharma USA Inc. |
BUPIVACAINE HYDROCHLORIDE |
2.5 mg/mL |
10 VIAL in 1 CARTON (72266-263-10) / 10 mL in 1 VIAL |