Details for New Drug Application (NDA): 020610
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The generic ingredient in COLAZAL 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 020610
| Tradename: | COLAZAL |
| Applicant: | Valeant Pharms Intl |
| Ingredient: | balsalazide disodium |
| Patents: | 2 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 750MG | ||||
| Approval Date: | Jul 18, 2000 | TE: | AB | RLD: | Yes | ||||
| Patent: | 7,452,872*PED | Patent Expiration: | Feb 24, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 7,625,884*PED | Patent Expiration: | Feb 24, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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