Details for New Drug Application (NDA): 208953
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NDA 208953 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 208953
| Tradename: | MESALAMINE |
| Applicant: | Zydus Pharms |
| Ingredient: | mesalamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208953
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MESALAMINE | mesalamine | SUPPOSITORY;RECTAL | 208953 | ANDA | Northstar Rx LLC. | 16714-245 | 16714-245-30 | 5 BLISTER PACK in 1 POUCH (16714-245-30) / 6 SUPPOSITORY in 1 BLISTER PACK (16714-245-01) |
| MESALAMINE | mesalamine | SUPPOSITORY;RECTAL | 208953 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1302 | 70710-1302-7 | 5 BLISTER PACK in 1 POUCH (70710-1302-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70710-1302-6) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUPPOSITORY;RECTAL | Strength | 1GM | ||||
| Approval Date: | Feb 12, 2020 | TE: | AB | RLD: | No | ||||
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