Details for New Drug Application (NDA): 214242
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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 214242
Tradename: | MESALAMINE |
Applicant: | Alkem Labs Ltd |
Ingredient: | mesalamine |
Patents: | 0 |
Suppliers and Packaging for NDA: 214242
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MESALAMINE | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 214242 | ANDA | AvPAK | 50268-577 | 50268-577-15 | 50 BLISTER PACK in 1 BOX (50268-577-15) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-577-11) |
MESALAMINE | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 214242 | ANDA | American Health Packaging | 60687-650 | 60687-650-32 | 20 BLISTER PACK in 1 CARTON (60687-650-32) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (60687-650-33) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 375MG | ||||
Approval Date: | Jul 15, 2021 | TE: | AB | RLD: | No |
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