Details for New Drug Application (NDA): 091640
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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 091640
Tradename: | MESALAMINE |
Applicant: | Zydus Pharms |
Ingredient: | mesalamine |
Patents: | 0 |
Suppliers and Packaging for NDA: 091640
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MESALAMINE | mesalamine | TABLET, DELAYED RELEASE;ORAL | 091640 | ANDA | Major Pharmaceuticals | 0904-6832 | 0904-6832-04 | 30 BLISTER PACK in 1 CARTON (0904-6832-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
MESALAMINE | mesalamine | TABLET, DELAYED RELEASE;ORAL | 091640 | ANDA | Northstar Rx LLC. | 16714-830 | 16714-830-01 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (16714-830-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 1.2GM | ||||
Approval Date: | Jun 5, 2017 | TE: | AB | RLD: | No |
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