Details for New Drug Application (NDA): 219028
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NDA 219028 describes MESALAMINE, which is a drug marketed by Teva Pharms Usa, Alembic, Alkem Labs Ltd, Amta, Annora Pharma, Aurobindo Pharma Ltd, Mylan, Novast Labs, Sun Pharm, Zydus Pharms, Encube, G And W Labs Inc, Novitium Pharma, Padagis Israel, Actavis Mid Atlantic, Amneal, Amring Pharms, Quagen, Rising, Sandoz, Actavis Labs Fl, Sinotherapeutics Inc, and Teva Pharms Inc, and is included in thirty-three NDAs. It is available from thirty suppliers. Additional details are available on the MESALAMINE profile page.
The generic ingredient in MESALAMINE is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
The generic ingredient in MESALAMINE is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 219028
| Tradename: | MESALAMINE |
| Applicant: | Rising |
| Ingredient: | mesalamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219028
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MESALAMINE | mesalamine | SUPPOSITORY;RECTAL | 219028 | ANDA | Rising Pharma Holdings, Inc. | 16571-246 | 16571-246-03 | 5 BLISTER PACK in 1 CARTON (16571-246-03) / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16) |
| MESALAMINE | mesalamine | SUPPOSITORY;RECTAL | 219028 | ANDA | Rising Pharma Holdings, Inc. | 16571-246 | 16571-246-72 | 12 BLISTER PACK in 1 CARTON (16571-246-72) / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUPPOSITORY;RECTAL | Strength | 1GM | ||||
| Approval Date: | Apr 14, 2025 | TE: | AB | RLD: | No | ||||
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