Details for New Drug Application (NDA): 077806
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NDA 077806 describes BALSALAZIDE DISODIUM, which is a drug marketed by Apotex Inc, Dash Pharms Natco, Hikma, Zydus Lifesciences, and Strides Pharma, and is included in five NDAs. It is available from eight suppliers. Additional details are available on the BALSALAZIDE DISODIUM profile page.
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.
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 077806
| Tradename: | BALSALAZIDE DISODIUM |
| Applicant: | Hikma |
| Ingredient: | balsalazide disodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 077806
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BALSALAZIDE DISODIUM | balsalazide disodium | CAPSULE;ORAL | 077806 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0079 | 0054-0079-28 | 280 CAPSULE in 1 BOTTLE (0054-0079-28) |
| BALSALAZIDE DISODIUM | balsalazide disodium | CAPSULE;ORAL | 077806 | ANDA | Golden State Medical Supply, Inc. | 51407-820 | 51407-820-28 | 280 CAPSULE in 1 BOTTLE (51407-820-28) |
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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