Details for New Drug Application (NDA): 213983
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NDA 213983 describes TIVICAY PD, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the TIVICAY PD profile page.
The generic ingredient in TIVICAY PD is dolutegravir sodium. There are seventeen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.
The generic ingredient in TIVICAY PD is dolutegravir sodium. There are seventeen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.
Summary for 213983
| Tradename: | TIVICAY PD |
| Applicant: | Viiv Hlthcare |
| Ingredient: | dolutegravir sodium |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213983
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 213983
Suppliers and Packaging for NDA: 213983
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIVICAY PD | dolutegravir sodium | TABLET, FOR SUSPENSION;ORAL | 213983 | NDA | ViiV Healthcare Company | 49702-255 | 49702-255-37 | 1 BOTTLE in 1 CARTON (49702-255-37) / 60 TABLET, FOR SUSPENSION in 1 BOTTLE |
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