Details for New Drug Application (NDA): 217592
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The generic ingredient in BALSALAZIDE DISODIUM is balsalazide disodium. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the balsalazide disodium profile page.
Summary for 217592
Tradename: | BALSALAZIDE DISODIUM |
Applicant: | Zydus Lifesciences |
Ingredient: | balsalazide disodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 217592
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BALSALAZIDE DISODIUM | balsalazide disodium | CAPSULE;ORAL | 217592 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1626 | 70710-1626-1 | 280 CAPSULE in 1 BOTTLE (70710-1626-1) |
BALSALAZIDE DISODIUM | balsalazide disodium | CAPSULE;ORAL | 217592 | ANDA | Zydus Lifesciences Limited | 70771-1841 | 70771-1841-1 | 280 CAPSULE in 1 BOTTLE (70771-1841-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 750MG | ||||
Approval Date: | Jun 8, 2023 | TE: | AB | RLD: | No |
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