62559-420-07 |
62559-420 |
HUMAN PRESCRIPTION DRUG |
Mesalamine |
Mesalamine |
ENEMA |
RECTAL |
20160513 |
N/A |
NDA AUTHORIZED GENERIC |
NDA019618 |
ANI Pharmaceuticals, Inc. |
MESALAMINE |
4 g/60mL |
7 BOTTLE in 1 BOX (62559-420-07) / 60 mL in 1 BOTTLE (62559-420-11) |
0037-0022-07 |
0037-0022 |
HUMAN PRESCRIPTION DRUG |
sfRowasa Sulfite-Free Formulation |
mesalamine |
SUSPENSION |
RECTAL |
20160324 |
N/A |
NDA |
NDA019618 |
Meda Pharmaceuticals Inc. |
MESALAMINE |
4 g/60mL |
7 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-07) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60) |
0037-0022-28 |
0037-0022 |
HUMAN PRESCRIPTION DRUG |
sfRowasa Sulfite-Free Formulation |
mesalamine |
SUSPENSION |
RECTAL |
20160524 |
N/A |
NDA |
NDA019618 |
Meda Pharmaceuticals Inc. |
MESALAMINE |
4 g/60mL |
28 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-28) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60) |
0037-0066-03 |
0037-0066 |
HUMAN PRESCRIPTION DRUG |
Rowasa |
mesalamine |
SUSPENSION |
RECTAL |
20160324 |
N/A |
NDA |
NDA019618 |
Meda Pharmaceuticals Inc. |
MESALAMINE |
4 g/60mL |
28 BOTTLE, DISPENSING in 1 CARTON (0037-0066-03) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06) |
0037-0066-05 |
0037-0066 |
HUMAN PRESCRIPTION DRUG |
Rowasa |
mesalamine |
SUSPENSION |
RECTAL |
20160324 |
N/A |
NDA |
NDA019618 |
Meda Pharmaceuticals Inc. |
MESALAMINE |
4 g/60mL |
7 BOTTLE, DISPENSING in 1 CARTON (0037-0066-05) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06) |