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, 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 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. Forty 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. Forty 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 Private Limited | 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 Private Limited | 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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