Suppliers and packages for tradename: ROWASA
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ROWASA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | ROWASA | mesalamine | ENEMA;RECTAL | 019618 | NDA | Meda Pharmaceuticals Inc. | 0037-0022-07 | 7 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-07) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60) | 2016-03-24 |
| Mylan Speciality Lp | ROWASA | mesalamine | ENEMA;RECTAL | 019618 | NDA | Meda Pharmaceuticals Inc. | 0037-0022-28 | 28 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-28) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60) | 2016-03-24 |
| Mylan Speciality Lp | ROWASA | mesalamine | ENEMA;RECTAL | 019618 | NDA | Meda Pharmaceuticals Inc. | 0037-0066-03 | 28 BOTTLE, DISPENSING in 1 CARTON (0037-0066-03) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06) | 2016-03-24 |
| Mylan Speciality Lp | ROWASA | mesalamine | ENEMA;RECTAL | 019618 | NDA | Meda Pharmaceuticals Inc. | 0037-0066-05 | 7 BOTTLE, DISPENSING in 1 CARTON (0037-0066-05) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06) | 2016-03-24 |
| Mylan Speciality Lp | ROWASA | mesalamine | ENEMA;RECTAL | 019618 | NDA AUTHORIZED GENERIC | ANI Pharmaceuticals, Inc. | 62559-420-07 | 7 BOTTLE in 1 BOX (62559-420-07) / 60 mL in 1 BOTTLE (62559-420-11) | 2016-05-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
