Details for New Drug Application (NDA): 209347
✉ Email this page to a colleague
NDA 209347 describes GANZYK-RTU, which is a drug marketed by Exela Pharma and is included in one NDA. There is one patent protecting this drug. Additional details are available on the GANZYK-RTU profile page.
The generic ingredient in GANZYK-RTU is ganciclovir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ganciclovir profile page.
The generic ingredient in GANZYK-RTU is ganciclovir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ganciclovir profile page.
Summary for 209347
| Tradename: | GANZYK-RTU |
| Applicant: | Exela Pharma |
| Ingredient: | ganciclovir |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209347
Generic Entry Date for 209347*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*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.
Medical Subject Heading (MeSH) Categories for 209347
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 500MG/250ML (2MG/ML) | ||||
| Approval Date: | Feb 17, 2017 | TE: | RLD: | Yes | |||||
| Patent: | 9,486,530 | Patent Expiration: | Sep 2, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
