Details for New Drug Application (NDA): 211858
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NDA 211858 describes MESALAMINE, which is a drug marketed by Teva Pharms Usa, Alembic, Alkem Labs Ltd, Amta, Aurobindo Pharma Ltd, Mylan, Novast Labs, Sun Pharm, Zydus Pharms, Encube, G And W Labs Inc, Padagis Israel, Actavis Mid Atlantic, Amneal, Amring Pharms, Annora Pharma, Rising, Sandoz, Actavis Labs Fl, Sinotherapeutics Inc, and Teva Pharms Inc, and is included in twenty-nine NDAs. It is available from twenty-nine 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 211858
| Tradename: | MESALAMINE |
| Applicant: | Sun Pharm |
| Ingredient: | mesalamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211858
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MESALAMINE | mesalamine | TABLET, DELAYED RELEASE;ORAL | 211858 | ANDA | Golden State Medical Supply, Inc. | 51407-274 | 51407-274-12 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (51407-274-12) |
| MESALAMINE | mesalamine | TABLET, DELAYED RELEASE;ORAL | 211858 | ANDA | Sun Pharmaceutical Industries, Inc. | 63304-175 | 63304-175-13 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (63304-175-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 1.2GM | ||||
| Approval Date: | Jan 25, 2019 | TE: | AB | RLD: | No | ||||
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