Details for New Drug Application (NDA): 022205
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The generic ingredient in GIAZO 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 022205
Tradename: | GIAZO |
Applicant: | Valeant Pharms Intl |
Ingredient: | balsalazide disodium |
Patents: | 4 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 3, 2012 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 24, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 24, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 23, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS |
Expired US Patents for NDA 022205
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Valeant Pharms Intl | GIAZO | balsalazide disodium | TABLET;ORAL | 022205-001 | Feb 3, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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