| 60687-760-86 |
60687-760 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20230801 |
20270228 |
NDA |
NDA022195 |
American Health Packaging |
MORPHINE SULFATE |
10 mg/5mL |
3 TRAY in 1 CASE (60687-760-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-760-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-760-40) |
| 17856-0237-5 |
17856-0237 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20240520 |
N/A |
NDA |
NDA022195 |
ATLANTIC BIOLOGICALS CORP. |
MORPHINE SULFATE |
10 mg/5mL |
5 mL in 1 CUP (17856-0237-5) |
| 17856-0238-2 |
17856-0238 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20240520 |
N/A |
NDA |
NDA022195 |
ATLANTIC BIOLOGICALS CORP. |
MORPHINE SULFATE |
20 mg/5mL |
60 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0238-2) / 2.5 mL in 1 CUP, UNIT-DOSE |
| 17856-0238-3 |
17856-0238 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20240520 |
N/A |
NDA |
NDA022195 |
ATLANTIC BIOLOGICALS CORP. |
MORPHINE SULFATE |
20 mg/5mL |
60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0238-3) / 5 mL in 1 SYRINGE |
| 17856-0238-5 |
17856-0238 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20240520 |
N/A |
NDA |
NDA022195 |
ATLANTIC BIOLOGICALS CORP. |
MORPHINE SULFATE |
20 mg/5mL |
5 mL in 1 CUP, UNIT-DOSE (17856-0238-5) |
| 17856-0237-2 |
17856-0237 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20240520 |
N/A |
NDA |
NDA022195 |
ATLANTIC BIOLOGICALS CORP. |
MORPHINE SULFATE |
10 mg/5mL |
120 PACKAGE in 1 BOX, UNIT-DOSE (17856-0237-2) / .5 mL in 1 PACKAGE |
| 17856-0237-1 |
17856-0237 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20240520 |
N/A |
NDA |
NDA022195 |
ATLANTIC BIOLOGICALS CORP. |
MORPHINE SULFATE |
10 mg/5mL |
.5 mL in 1 SYRINGE, PLASTIC (17856-0237-1) |
| 17856-0238-1 |
17856-0238 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20240520 |
N/A |
NDA |
NDA022195 |
ATLANTIC BIOLOGICALS CORP. |
MORPHINE SULFATE |
20 mg/5mL |
60 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0238-1) / 1.25 mL in 1 CUP, UNIT-DOSE |
| 0121-0904-94 |
0121-0904 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20201009 |
N/A |
NDA |
NDA022195 |
PAI Holdings, LLC dba PAI Pharma |
MORPHINE SULFATE |
10 mg/5mL |
3 TRAY in 1 CASE (0121-0904-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0904-05) |
| 68094-156-58 |
68094-156 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20250606 |
N/A |
NDA |
NDA022195 |
Precision Dose, Inc. |
MORPHINE SULFATE |
100 mg/5mL |
50 BAG in 1 CASE (68094-156-58) / 1 SYRINGE, PLASTIC in 1 BAG / 1 mL in 1 SYRINGE, PLASTIC (68094-156-01) |
| 68094-001-62 |
68094-001 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20160229 |
N/A |
NDA |
NDA022195 |
Precision Dose Inc. |
MORPHINE SULFATE |
10 mg/5mL |
3 TRAY in 1 CASE (68094-001-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-001-59) |
| 68094-045-58 |
68094-045 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20201101 |
N/A |
NDA |
NDA022195 |
Precision Dose, Inc. |
MORPHINE SULFATE |
100 mg/5mL |
50 BAG in 1 CASE (68094-045-58) / 1 SYRINGE in 1 BAG / .5 mL in 1 SYRINGE (68094-045-01) |
| 68094-056-58 |
68094-056 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20220930 |
N/A |
NDA |
NDA022195 |
Precision Dose, Inc. |
MORPHINE SULFATE |
100 mg/5mL |
50 BAG in 1 CASE (68094-056-58) / 1 SYRINGE in 1 BAG / .5 mL in 1 SYRINGE (68094-056-01) |
| 68094-256-58 |
68094-256 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20230815 |
N/A |
NDA |
NDA022195 |
Precision Dose, Inc. |
MORPHINE SULFATE |
100 mg/5mL |
50 BAG in 1 CASE (68094-256-58) / 1 SYRINGE, PLASTIC in 1 BAG / .5 mL in 1 SYRINGE, PLASTIC (68094-256-01) |
| 68094-356-58 |
68094-356 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20231130 |
N/A |
NDA |
NDA022195 |
Precision Dose, Inc. |
MORPHINE SULFATE |
100 mg/5mL |
50 BAG in 1 CASE (68094-356-58) / 1 SYRINGE, PLASTIC in 1 BAG / 1 mL in 1 SYRINGE, PLASTIC (68094-356-01) |
| 68094-556-58 |
68094-556 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20250901 |
N/A |
NDA |
NDA022195 |
Precision Dose, Inc. |
MORPHINE SULFATE |
100 mg/5mL |
50 BAG in 1 CASE (68094-556-58) / 1 SYRINGE, PLASTIC in 1 BAG / .25 mL in 1 SYRINGE, PLASTIC (68094-556-01) |
| 0054-0237-63 |
0054-0237 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20080317 |
N/A |
NDA |
NDA022195 |
Hikma Pharmaceuticals USA Inc. |
MORPHINE SULFATE |
10 mg/5mL |
500 mL in 1 BOTTLE (0054-0237-63) |
| 0054-0238-49 |
0054-0238 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20080317 |
N/A |
NDA |
NDA022195 |
Hikma Pharmaceuticals USA Inc. |
MORPHINE SULFATE |
20 mg/5mL |
100 mL in 1 BOTTLE (0054-0238-49) |
| 0054-0238-63 |
0054-0238 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20080317 |
N/A |
NDA |
NDA022195 |
Hikma Pharmaceuticals USA Inc. |
MORPHINE SULFATE |
20 mg/5mL |
500 mL in 1 BOTTLE (0054-0238-63) |
| 0054-0237-49 |
0054-0237 |
HUMAN PRESCRIPTION DRUG |
Morphine Sulfate |
Morphine Sulfate |
SOLUTION |
ORAL |
20080317 |
N/A |
NDA |
NDA022195 |
Hikma Pharmaceuticals USA Inc. |
MORPHINE SULFATE |
10 mg/5mL |
100 mL in 1 BOTTLE (0054-0237-49) |