| 82449-225-02 |
82449-225 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine Hydrochloride |
Bupivacaine Hydrochloride |
INJECTION, SOLUTION |
EPIDURAL |
20230609 |
N/A |
ANDA |
ANDA091487 |
Steriscience Specialties Private Limited |
BUPIVACAINE HYDROCHLORIDE |
5 mg/mL |
10 VIAL in 1 CARTON (82449-225-02) / 10 mL in 1 VIAL |
| 82449-226-01 |
82449-226 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine Hydrochloride |
Bupivacaine Hydrochloride |
INJECTION, SOLUTION |
EPIDURAL |
20230609 |
N/A |
ANDA |
ANDA091487 |
Steriscience Specialties Private Limited |
BUPIVACAINE HYDROCHLORIDE |
5 mg/mL |
1 VIAL in 1 CARTON (82449-226-01) / 30 mL in 1 VIAL |
| 82449-227-02 |
82449-227 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine Hydrochloride |
Bupivacaine Hydrochloride |
INJECTION, SOLUTION |
EPIDURAL; RETROBULBAR |
20230609 |
N/A |
ANDA |
ANDA091487 |
Steriscience Specialties Private Limited |
BUPIVACAINE HYDROCHLORIDE |
7.5 mg/mL |
10 VIAL in 1 CARTON (82449-227-02) / 10 mL in 1 VIAL |
| 82449-228-01 |
82449-228 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine Hydrochloride |
Bupivacaine Hydrochloride |
INJECTION, SOLUTION |
EPIDURAL; RETROBULBAR |
20230609 |
N/A |
ANDA |
ANDA091487 |
Steriscience Specialties Private Limited |
BUPIVACAINE HYDROCHLORIDE |
7.5 mg/mL |
1 VIAL in 1 CARTON (82449-228-01) / 30 mL in 1 VIAL |
| 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) |
| 82449-224-01 |
82449-224 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine Hydrochloride |
Bupivacaine Hydrochloride |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION |
20230609 |
N/A |
ANDA |
ANDA091487 |
Steriscience Specialties Private Limited |
BUPIVACAINE HYDROCHLORIDE |
2.5 mg/mL |
1 VIAL in 1 CARTON (82449-224-01) / 30 mL in 1 VIAL |
| 82449-223-02 |
82449-223 |
HUMAN PRESCRIPTION DRUG |
Bupivacaine Hydrochloride |
Bupivacaine Hydrochloride |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION |
20230609 |
N/A |
ANDA |
ANDA091487 |
Steriscience Specialties Private Limited |
BUPIVACAINE HYDROCHLORIDE |
2.5 mg/mL |
10 VIAL in 1 CARTON (82449-223-02) / 10 mL in 1 VIAL |