Details for New Drug Application (NDA): 207873
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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 207873
Tradename: | MESALAMINE |
Applicant: | Teva Pharms Usa |
Ingredient: | mesalamine |
Patents: | 0 |
Suppliers and Packaging for NDA: 207873
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MESALAMINE | mesalamine | CAPSULE, DELAYED RELEASE;ORAL | 207873 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5907 | 0093-5907-86 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-5907-86) |
MESALAMINE | mesalamine | CAPSULE, DELAYED RELEASE;ORAL | 207873 | ANDA | American Health Packaging | 60687-556 | 60687-556-32 | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-556-32) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (60687-556-33) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 400MG | ||||
Approval Date: | May 9, 2019 | TE: | AB | RLD: | No |
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