| 82604-600-00 |
82604-600 |
HUMAN PRESCRIPTION DRUG |
Omidria |
phenylephrine and ketorolac |
INJECTION, SOLUTION, CONCENTRATE |
INTRAOCULAR |
20230701 |
N/A |
NDA |
NDA205388 |
Rayner Surgical Inc. |
KETOROLAC; PHENYLEPHRINE |
2.88 mg/mL; 10.16 mg/mL |
1 VIAL in 1 CARTON (82604-600-00) / 4 mL in 1 VIAL |
| 82604-600-04 |
82604-600 |
HUMAN PRESCRIPTION DRUG |
Omidria |
phenylephrine and ketorolac |
INJECTION, SOLUTION, CONCENTRATE |
INTRAOCULAR |
20230701 |
N/A |
NDA |
NDA205388 |
Rayner Surgical Inc. |
KETOROLAC; PHENYLEPHRINE |
2.88 mg/mL; 10.16 mg/mL |
4 VIAL in 1 CARTON (82604-600-04) / 4 mL in 1 VIAL |
| 82604-600-99 |
82604-600 |
HUMAN PRESCRIPTION DRUG |
Omidria |
phenylephrine and ketorolac |
INJECTION, SOLUTION, CONCENTRATE |
INTRAOCULAR |
20230701 |
N/A |
NDA |
NDA205388 |
Rayner Surgical Inc. |
KETOROLAC; PHENYLEPHRINE |
2.88 mg/mL; 10.16 mg/mL |
4 VIAL in 1 CARTON (82604-600-99) / 4 mL in 1 VIAL |