| 81140-101-10 |
81140-101 |
HUMAN PRESCRIPTION DRUG |
RoxyBond |
Oxycodone hydrochloride |
TABLET, COATED |
ORAL |
20231219 |
N/A |
NDA |
NDA209777 |
Protega Pharmaceuticals Inc |
OXYCODONE HYDROCHLORIDE |
5 mg/1 |
100 TABLET, COATED in 1 BOTTLE (81140-101-10) |
| 73780-002-10 |
73780-002 |
HUMAN PRESCRIPTION DRUG |
OXYCODONE HYDROCHLORIDE |
Oxycodone hydrochloride |
TABLET, COATED |
ORAL |
20240909 |
N/A |
NDA AUTHORIZED GENERIC |
NDA209777 |
Ohemo Life Sciences Inc. |
OXYCODONE HYDROCHLORIDE |
10 mg/1 |
100 TABLET, COATED in 1 BOTTLE (73780-002-10) |
| 73780-001-10 |
73780-001 |
HUMAN PRESCRIPTION DRUG |
OXYCODONE HYDROCHLORIDE |
Oxycodone hydrochloride |
TABLET, COATED |
ORAL |
20240701 |
N/A |
NDA AUTHORIZED GENERIC |
NDA209777 |
Ohemo Life Sciences Inc. |
OXYCODONE HYDROCHLORIDE |
5 mg/1 |
100 TABLET, COATED in 1 BOTTLE (73780-001-10) |
| 81140-104-10 |
81140-104 |
HUMAN PRESCRIPTION DRUG |
RoxyBond |
Oxycodone hydrochloride |
TABLET, COATED |
ORAL |
20231219 |
N/A |
NDA |
NDA209777 |
Protega Pharmaceuticals Inc |
OXYCODONE HYDROCHLORIDE |
10 mg/1 |
100 TABLET, COATED in 1 BOTTLE (81140-104-10) |
| 81140-103-10 |
81140-103 |
HUMAN PRESCRIPTION DRUG |
RoxyBond |
Oxycodone hydrochloride |
TABLET, COATED |
ORAL |
20231219 |
N/A |
NDA |
NDA209777 |
Protega Pharmaceuticals Inc |
OXYCODONE HYDROCHLORIDE |
30 mg/1 |
100 TABLET, COATED in 1 BOTTLE (81140-103-10) |
| 73780-004-10 |
73780-004 |
HUMAN PRESCRIPTION DRUG |
OXYCODONE HYDROCHLORIDE |
Oxycodone hydrochloride |
TABLET, COATED |
ORAL |
20240701 |
N/A |
NDA AUTHORIZED GENERIC |
NDA209777 |
Ohemo Life Sciences Inc. |
OXYCODONE HYDROCHLORIDE |
30 mg/1 |
100 TABLET, COATED in 1 BOTTLE (73780-004-10) |
| 81140-102-10 |
81140-102 |
HUMAN PRESCRIPTION DRUG |
RoxyBond |
Oxycodone hydrochloride |
TABLET, COATED |
ORAL |
20231219 |
N/A |
NDA |
NDA209777 |
Protega Pharmaceuticals Inc |
OXYCODONE HYDROCHLORIDE |
15 mg/1 |
100 TABLET, COATED in 1 BOTTLE (81140-102-10) |
| 73780-003-10 |
73780-003 |
HUMAN PRESCRIPTION DRUG |
OXYCODONE HYDROCHLORIDE |
Oxycodone hydrochloride |
TABLET, COATED |
ORAL |
20240701 |
N/A |
NDA AUTHORIZED GENERIC |
NDA209777 |
Ohemo Life Sciences Inc. |
OXYCODONE HYDROCHLORIDE |
15 mg/1 |
100 TABLET, COATED in 1 BOTTLE (73780-003-10) |