65649-103-01 |
65649-103 |
HUMAN PRESCRIPTION DRUG |
APRISO |
mesalamine |
CAPSULE, EXTENDED RELEASE |
ORAL |
20081031 |
N/A |
NDA |
NDA022301 |
Salix Pharmaceuticals, Inc. |
MESALAMINE |
375 mg/1 |
1 BOTTLE in 1 CARTON (65649-103-01) / 4 CAPSULE, EXTENDED RELEASE in 1 BOTTLE |
65649-103-02 |
65649-103 |
HUMAN PRESCRIPTION DRUG |
APRISO |
mesalamine |
CAPSULE, EXTENDED RELEASE |
ORAL |
20081031 |
N/A |
NDA |
NDA022301 |
Salix Pharmaceuticals, Inc. |
MESALAMINE |
375 mg/1 |
1 BOTTLE in 1 CARTON (65649-103-02) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE |
0093-9224-89 |
0093-9224 |
HUMAN PRESCRIPTION DRUG |
mesalamine |
mesalamine |
CAPSULE, EXTENDED RELEASE |
ORAL |
20210105 |
N/A |
NDA AUTHORIZED GENERIC |
NDA022301 |
Teva Pharmaceuticals USA, Inc. |
MESALAMINE |
375 mg/1 |
120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-9224-89) |
70748-214-16 |
70748-214 |
HUMAN PRESCRIPTION DRUG |
mesalamine |
mesalamine |
CAPSULE, EXTENDED RELEASE |
ORAL |
20200518 |
20250831 |
NDA AUTHORIZED GENERIC |
NDA022301 |
Lupin Pharmaceuticals, Inc. |
MESALAMINE |
375 mg/1 |
120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70748-214-16) |
68682-113-20 |
68682-113 |
HUMAN PRESCRIPTION DRUG |
mesalamine |
mesalamine |
CAPSULE, EXTENDED RELEASE |
ORAL |
20180719 |
N/A |
NDA AUTHORIZED GENERIC |
NDA022301 |
Oceanside Pharmaceuticals |
MESALAMINE |
375 mg/1 |
1 BOTTLE in 1 CARTON (68682-113-20) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE |
43353-884-79 |
43353-884 |
HUMAN PRESCRIPTION DRUG |
APRISO |
mesalamine |
CAPSULE, EXTENDED RELEASE |
ORAL |
20140217 |
N/A |
NDA |
NDA022301 |
Aphena Pharma Solutions - Tennessee, LLC |
MESALAMINE |
375 mg/1 |
2160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43353-884-79) |
63629-8827-1 |
63629-8827 |
HUMAN PRESCRIPTION DRUG |
mesalamine |
mesalamine |
CAPSULE, EXTENDED RELEASE |
ORAL |
20210910 |
N/A |
NDA AUTHORIZED GENERIC |
NDA022301 |
Bryant Ranch Prepack |
MESALAMINE |
375 mg/1 |
120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8827-1) |