| 23635-524-60 |
23635-524 |
HUMAN PRESCRIPTION DRUG |
Amitiza |
lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20240401 |
N/A |
NDA |
NDA021908 |
SpecGx LLC |
LUBIPROSTONE |
24 ug/1 |
60 CAPSULE, GELATIN COATED in 1 BOTTLE (23635-524-60) |
| 0406-6424-60 |
0406-6424 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
Lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20240501 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
SpecGx LLC |
LUBIPROSTONE |
24 ug/1 |
60 CAPSULE, GELATIN COATED in 1 BOTTLE (0406-6424-60) |
| 63304-352-60 |
63304-352 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20230101 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
Sun Pharmaceutical Industries, Inc. |
LUBIPROSTONE |
24 ug/1 |
60 CAPSULE, GELATIN COATED in 1 BOTTLE (63304-352-60) |
| 76420-906-01 |
76420-906 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20250128 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
Asclemed USA, Inc. |
LUBIPROSTONE |
8 ug/1 |
100 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-01) |
| 76420-906-30 |
76420-906 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20250128 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
Asclemed USA, Inc. |
LUBIPROSTONE |
8 ug/1 |
30 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-30) |
| 76420-906-60 |
76420-906 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20250128 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
Asclemed USA, Inc. |
LUBIPROSTONE |
8 ug/1 |
60 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-60) |
| 76420-906-90 |
76420-906 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20250128 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
Asclemed USA, Inc. |
LUBIPROSTONE |
8 ug/1 |
90 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-90) |
| 71205-831-00 |
71205-831 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20231018 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
Proficient Rx LP |
LUBIPROSTONE |
8 ug/1 |
100 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-00) |
| 71205-831-11 |
71205-831 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20231018 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
Proficient Rx LP |
LUBIPROSTONE |
8 ug/1 |
1000 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-11) |
| 71205-831-30 |
71205-831 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20231018 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
Proficient Rx LP |
LUBIPROSTONE |
8 ug/1 |
30 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-30) |
| 23635-508-60 |
23635-508 |
HUMAN PRESCRIPTION DRUG |
Amitiza |
lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20240401 |
N/A |
NDA |
NDA021908 |
SpecGx LLC |
LUBIPROSTONE |
8 ug/1 |
60 CAPSULE, GELATIN COATED in 1 BOTTLE (23635-508-60) |
| 0406-6408-60 |
0406-6408 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
Lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20240501 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
SpecGx LLC |
LUBIPROSTONE |
8 ug/1 |
60 CAPSULE, GELATIN COATED in 1 BOTTLE (0406-6408-60) |
| 83008-001-60 |
83008-001 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20230314 |
20260831 |
NDA AUTHORIZED GENERIC |
NDA021908 |
Quality Care Products, LLC |
LUBIPROSTONE |
24 ug/1 |
60 CAPSULE, GELATIN COATED in 1 BOTTLE (83008-001-60) |
| 63304-351-60 |
63304-351 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20230101 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
Sun Pharmaceutical Industries, Inc. |
LUBIPROSTONE |
8 ug/1 |
60 CAPSULE, GELATIN COATED in 1 BOTTLE (63304-351-60) |
| 55700-963-60 |
55700-963 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
Lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20220217 |
20260531 |
NDA AUTHORIZED GENERIC |
NDA021908 |
Quality Care Products, LLC |
LUBIPROSTONE |
24 ug/1 |
60 CAPSULE, GELATIN COATED in 1 BOTTLE (55700-963-60) |
| 43598-163-60 |
43598-163 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
Lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20230101 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
Dr. Reddy's Laboratories Inc. |
LUBIPROSTONE |
8 ug/1 |
60 CAPSULE, GELATIN COATED in 1 BOTTLE (43598-163-60) |
| 69339-162-17 |
69339-162 |
HUMAN PRESCRIPTION DRUG |
LUBIPROSTONE |
LUBIPROSTONE |
CAPSULE |
ORAL |
20221017 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
Natco Pharma USA LLC |
LUBIPROSTONE |
8 ug/1 |
40 BLISTER PACK in 1 CARTON (69339-162-17) / 1 CAPSULE in 1 BLISTER PACK (69339-162-98) |
| 71205-831-55 |
71205-831 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20231018 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
Proficient Rx LP |
LUBIPROSTONE |
8 ug/1 |
500 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-55) |
| 71205-831-60 |
71205-831 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20231018 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
Proficient Rx LP |
LUBIPROSTONE |
8 ug/1 |
60 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-60) |
| 71205-831-64 |
71205-831 |
HUMAN PRESCRIPTION DRUG |
Lubiprostone |
lubiprostone |
CAPSULE, GELATIN COATED |
ORAL |
20231018 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021908 |
Proficient Rx LP |
LUBIPROSTONE |
8 ug/1 |
240 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-64) |