63402-193-03 |
63402-193 |
HUMAN PRESCRIPTION DRUG |
Lunesta |
ESZOPICLONE |
TABLET, COATED |
ORAL |
20181101 |
20250731 |
NDA |
NDA021476 |
Sumitomo Pharma America, Inc. |
ESZOPICLONE |
3 mg/1 |
30 TABLET, COATED in 1 BOTTLE (63402-193-03) |
63402-191-03 |
63402-191 |
HUMAN PRESCRIPTION DRUG |
Lunesta |
ESZOPICLONE |
TABLET, COATED |
ORAL |
20181101 |
20250131 |
NDA |
NDA021476 |
Sumitomo Pharma America, Inc. |
ESZOPICLONE |
2 mg/1 |
30 TABLET, COATED in 1 BOTTLE (63402-191-03) |
63402-190-30 |
63402-190 |
HUMAN PRESCRIPTION DRUG |
Lunesta |
ESZOPICLONE |
TABLET, COATED |
ORAL |
20080527 |
20250731 |
NDA |
NDA021476 |
Sumitomo Pharma America, Inc. |
ESZOPICLONE |
1 mg/1 |
30 TABLET, COATED in 1 BOTTLE (63402-190-30) |
80725-010-30 |
80725-010 |
HUMAN PRESCRIPTION DRUG |
Lunesta |
ESZOPICLONE |
TABLET, COATED |
ORAL |
20230815 |
N/A |
NDA |
NDA021476 |
Waylis Therapeutics LLC |
ESZOPICLONE |
1 mg/1 |
30 TABLET, COATED in 1 BOTTLE (80725-010-30) |
80725-011-30 |
80725-011 |
HUMAN PRESCRIPTION DRUG |
Lunesta |
ESZOPICLONE |
TABLET, COATED |
ORAL |
20230815 |
N/A |
NDA |
NDA021476 |
Waylis Therapeutics LLC |
ESZOPICLONE |
2 mg/1 |
30 TABLET, COATED in 1 BOTTLE (80725-011-30) |
80725-012-30 |
80725-012 |
HUMAN PRESCRIPTION DRUG |
Lunesta |
ESZOPICLONE |
TABLET, COATED |
ORAL |
20230815 |
N/A |
NDA |
NDA021476 |
Waylis Therapeutics LLC |
ESZOPICLONE |
3 mg/1 |
30 TABLET, COATED in 1 BOTTLE (80725-012-30) |