Details for New Drug Application (NDA): 216941
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NDA 216941 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 216941
| Tradename: | MESALAMINE |
| Applicant: | Encube |
| Ingredient: | mesalamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216941
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MESALAMINE | mesalamine | ENEMA;RECTAL | 216941 | ANDA | Encube Ethicals, Inc. | 21922-045 | 21922-045-47 | 7 BOTTLE, DISPENSING in 1 CARTON (21922-045-47) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01) |
| MESALAMINE | mesalamine | ENEMA;RECTAL | 216941 | ANDA | Encube Ethicals, Inc. | 21922-045 | 21922-045-49 | 28 BOTTLE, DISPENSING in 1 CARTON (21922-045-49) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | ENEMA;RECTAL | Strength | 4GM/60ML | ||||
| Approval Date: | May 30, 2023 | TE: | AB | RLD: | No | ||||
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