| 71225-132-02 |
71225-132 |
HUMAN PRESCRIPTION DRUG |
DEXMEDETOMIDINE HYDROCHLORIDE |
dexmedetomidine hydrochloride |
INJECTION |
INTRAVENOUS |
20211020 |
N/A |
ANDA |
ANDA212791 |
Slayback Pharma LLC |
DEXMEDETOMIDINE HYDROCHLORIDE |
4 ug/mL |
10 BOTTLE in 1 CARTON (71225-132-02) / 50 mL in 1 BOTTLE (71225-132-01) |
| 72572-128-08 |
72572-128 |
HUMAN PRESCRIPTION DRUG |
DEXMEDETOMIDINE HYDROCHLORIDE |
dexmedetomidine hydrochloride |
INJECTION |
INTRAVENOUS |
20210823 |
N/A |
ANDA |
ANDA212791 |
CIVICA, INC. |
DEXMEDETOMIDINE HYDROCHLORIDE |
4 ug/mL |
8 BOTTLE in 1 CARTON (72572-128-08) / 100 mL in 1 BOTTLE (72572-128-01) |
| 71225-126-04 |
71225-126 |
HUMAN PRESCRIPTION DRUG |
DEXMEDETOMIDINE HYDROCHLORIDE |
dexmedetomidine hydrochloride |
INJECTION |
INTRAVENOUS |
20211211 |
20260731 |
ANDA |
ANDA212791 |
Slayback Pharma LLC |
DEXMEDETOMIDINE HYDROCHLORIDE |
4 ug/mL |
10 VIAL in 1 CARTON (71225-126-04) / 20 mL in 1 VIAL (71225-126-01) |
| 71225-126-05 |
71225-126 |
HUMAN PRESCRIPTION DRUG |
DEXMEDETOMIDINE HYDROCHLORIDE |
dexmedetomidine hydrochloride |
INJECTION |
INTRAVENOUS |
20191206 |
20260731 |
ANDA |
ANDA212791 |
Slayback Pharma LLC |
DEXMEDETOMIDINE HYDROCHLORIDE |
4 ug/mL |
20 BOTTLE in 1 CARTON (71225-126-05) / 50 mL in 1 BOTTLE (71225-126-02) |
| 71225-126-06 |
71225-126 |
HUMAN PRESCRIPTION DRUG |
DEXMEDETOMIDINE HYDROCHLORIDE |
dexmedetomidine hydrochloride |
INJECTION |
INTRAVENOUS |
20191206 |
20260731 |
ANDA |
ANDA212791 |
Slayback Pharma LLC |
DEXMEDETOMIDINE HYDROCHLORIDE |
4 ug/mL |
10 BOTTLE in 1 CARTON (71225-126-06) / 100 mL in 1 BOTTLE (71225-126-03) |
| 72572-127-10 |
72572-127 |
HUMAN PRESCRIPTION DRUG |
DEXMEDETOMIDINE HYDROCHLORIDE |
dexmedetomidine hydrochloride |
INJECTION |
INTRAVENOUS |
20210823 |
N/A |
ANDA |
ANDA212791 |
CIVICA, INC. |
DEXMEDETOMIDINE HYDROCHLORIDE |
4 ug/mL |
10 BOTTLE in 1 CARTON (72572-127-10) / 50 mL in 1 BOTTLE (72572-127-01) |
| 52536-126-08 |
52536-126 |
HUMAN PRESCRIPTION DRUG |
DEXMEDETOMIDINE HYDROCHLORIDE |
dexmedetomidine hydrochloride |
INJECTION |
INTRAVENOUS |
20250130 |
N/A |
ANDA |
ANDA212791 |
Wilshire Pharmaceuticals, Inc. |
DEXMEDETOMIDINE HYDROCHLORIDE |
4 ug/mL |
8 BOTTLE in 1 CARTON (52536-126-08) / 100 mL in 1 BOTTLE (52536-126-01) |
| 52536-125-10 |
52536-125 |
HUMAN PRESCRIPTION DRUG |
DEXMEDETOMIDINE HYDROCHLORIDE |
dexmedetomidine hydrochloride |
INJECTION |
INTRAVENOUS |
20250130 |
N/A |
ANDA |
ANDA212791 |
Wilshire Pharmaceuticals, Inc. |
DEXMEDETOMIDINE HYDROCHLORIDE |
4 ug/mL |
10 BOTTLE in 1 CARTON (52536-125-10) / 50 mL in 1 BOTTLE (52536-125-01) |
| 71225-133-02 |
71225-133 |
HUMAN PRESCRIPTION DRUG |
DEXMEDETOMIDINE HYDROCHLORIDE |
dexmedetomidine hydrochloride |
INJECTION |
INTRAVENOUS |
20211020 |
N/A |
ANDA |
ANDA212791 |
Slayback Pharma LLC |
DEXMEDETOMIDINE HYDROCHLORIDE |
4 ug/mL |
8 BOTTLE in 1 CARTON (71225-133-02) / 100 mL in 1 BOTTLE (71225-133-01) |