Details for New Drug Application (NDA): 209347
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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 |
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: | 9,486,530 | Patent Expiration: | Sep 2, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? |
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