| 83504-153-10 |
83504-153 |
HUMAN PRESCRIPTION DRUG |
EXXUA |
gepirone |
TABLET, EXTENDED RELEASE |
ORAL |
20240101 |
N/A |
NDA |
NDA021164 |
Fabre Kramer Pharmaceuticals, Inc. |
GEPIRONE HYDROCHLORIDE |
72.6 mg/1 |
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (83504-153-10) |
| 23594-151-30 |
23594-151 |
HUMAN PRESCRIPTION DRUG |
EXXUA |
gepirone |
TABLET, EXTENDED RELEASE |
ORAL |
20251001 |
N/A |
NDA |
NDA021164 |
Aytu Therapeutics, LLC |
GEPIRONE HYDROCHLORIDE |
36.3 mg/1 |
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-151-30) |
| 83504-152-10 |
83504-152 |
HUMAN PRESCRIPTION DRUG |
EXXUA |
gepirone |
TABLET, EXTENDED RELEASE |
ORAL |
20240101 |
N/A |
NDA |
NDA021164 |
Fabre Kramer Pharmaceuticals, Inc. |
GEPIRONE HYDROCHLORIDE |
54.5 mg/1 |
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (83504-152-10) |
| 23594-150-30 |
23594-150 |
HUMAN PRESCRIPTION DRUG |
EXXUA |
gepirone |
TABLET, EXTENDED RELEASE |
ORAL |
20251001 |
N/A |
NDA |
NDA021164 |
Aytu Therapeutics, LLC |
GEPIRONE HYDROCHLORIDE |
18.2 mg/1 |
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-150-30) |
| 23594-150-32 |
23594-150 |
HUMAN PRESCRIPTION DRUG |
EXXUA |
gepirone |
TABLET, EXTENDED RELEASE |
ORAL |
20251001 |
N/A |
NDA |
NDA021164 |
Aytu Therapeutics, LLC |
GEPIRONE HYDROCHLORIDE |
18.2 mg/1 |
32 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-150-32) |
| 83504-151-10 |
83504-151 |
HUMAN PRESCRIPTION DRUG |
EXXUA |
gepirone |
TABLET, EXTENDED RELEASE |
ORAL |
20240101 |
N/A |
NDA |
NDA021164 |
Fabre Kramer Pharmaceuticals, Inc. |
GEPIRONE HYDROCHLORIDE |
36.3 mg/1 |
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (83504-151-10) |
| 23594-153-30 |
23594-153 |
HUMAN PRESCRIPTION DRUG |
EXXUA |
gepirone |
TABLET, EXTENDED RELEASE |
ORAL |
20251001 |
N/A |
NDA |
NDA021164 |
Aytu Therapeutics, LLC |
GEPIRONE HYDROCHLORIDE |
72.6 mg/1 |
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-153-30) |
| 83504-150-10 |
83504-150 |
HUMAN PRESCRIPTION DRUG |
EXXUA |
gepirone |
TABLET, EXTENDED RELEASE |
ORAL |
20240101 |
N/A |
NDA |
NDA021164 |
Fabre Kramer Pharmaceuticals, Inc. |
GEPIRONE HYDROCHLORIDE |
18.2 mg/1 |
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (83504-150-10) |
| 23594-152-30 |
23594-152 |
HUMAN PRESCRIPTION DRUG |
EXXUA |
gepirone |
TABLET, EXTENDED RELEASE |
ORAL |
20251001 |
N/A |
NDA |
NDA021164 |
Aytu Therapeutics, LLC |
GEPIRONE HYDROCHLORIDE |
54.5 mg/1 |
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-152-30) |