Details for New Drug Application (NDA): 209347
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NDA 209347 describes GANZYK-RTU, which is a drug marketed by Exela Pharma and is included in one NDA. It is available from one supplier. 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 are twenty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ganciclovir profile page.
The generic ingredient in GANZYK-RTU is ganciclovir. There are twenty-seven drug master file entries for this compound. Two suppliers are 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 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209347
| Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 209347
Suppliers and Packaging for NDA: 209347
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GANZYK-RTU | ganciclovir | SOLUTION;INTRAVENOUS | 209347 | NDA | EXELA PHARMA SCIENCES, LLC | 51754-2500 | 51754-2500-1 | 250 mL in 1 BAG (51754-2500-1) |
| GANZYK-RTU | ganciclovir | SOLUTION;INTRAVENOUS | 209347 | NDA | EXELA PHARMA SCIENCES, LLC | 51754-2500 | 51754-2500-3 | 10 BAG in 1 POUCH (51754-2500-3) / 250 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 500MG/250ML (2MG/ML) | ||||
| Approval Date: | Feb 17, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 2, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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