Details for New Drug Application (NDA): 203286
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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 203286
Tradename: | MESALAMINE |
Applicant: | Zydus Pharms |
Ingredient: | mesalamine |
Patents: | 0 |
Suppliers and Packaging for NDA: 203286
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MESALAMINE | mesalamine | TABLET, DELAYED RELEASE;ORAL | 203286 | ANDA | American Health Packaging | 60687-408 | 60687-408-25 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-408-25) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-408-95) |
MESALAMINE | mesalamine | TABLET, DELAYED RELEASE;ORAL | 203286 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-435 | 68382-435-28 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-435-28) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 800MG | ||||
Approval Date: | Jul 21, 2017 | TE: | AB | RLD: | No |
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