Details for New Drug Application (NDA): 208169
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NDA 208169 describes XURIDEN, which is a drug marketed by Btg Intl and is included in one NDA. It is available from one supplier. Additional details are available on the XURIDEN profile page.
The generic ingredient in XURIDEN is uridine triacetate. There are thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.
The generic ingredient in XURIDEN is uridine triacetate. There are thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.
Summary for 208169
| Tradename: | XURIDEN |
| Applicant: | Btg Intl |
| Ingredient: | uridine triacetate |
| Patents: | 0 |
Pharmacology for NDA: 208169
| Ingredient-type | Analogs/Derivatives Pyrimidines |
Suppliers and Packaging for NDA: 208169
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XURIDEN | uridine triacetate | GRANULE;ORAL | 208169 | NDA | BTG International Inc | 50633-330 | 50633-330-30 | 30 PACKET in 1 CARTON (50633-330-30) / 2 g in 1 PACKET (50633-330-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 2GM/PACKET | ||||
| Approval Date: | Sep 4, 2015 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 208169
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Btg Intl | XURIDEN | uridine triacetate | GRANULE;ORAL | 208169-001 | Sep 4, 2015 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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