Details for New Drug Application (NDA): 077883
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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 077883
Tradename: | BALSALAZIDE DISODIUM |
Applicant: | Apotex Inc |
Ingredient: | balsalazide disodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 077883
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BALSALAZIDE DISODIUM | balsalazide disodium | CAPSULE;ORAL | 077883 | ANDA | AvPAK | 50268-102 | 50268-102-13 | 30 BLISTER PACK in 1 BOX (50268-102-13) / 1 CAPSULE in 1 BLISTER PACK (50268-102-11) |
BALSALAZIDE DISODIUM | balsalazide disodium | CAPSULE;ORAL | 077883 | ANDA | Apotex Corp. | 60505-2575 | 60505-2575-0 | 10 BLISTER PACK in 1 CARTON (60505-2575-0) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 750MG | ||||
Approval Date: | Dec 28, 2007 | TE: | AB | RLD: | No |
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