Details for New Drug Application (NDA): 022211
NDA 022211 describes ZIRGAN, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from one supplier. Additional details are available on the ZIRGAN profile page.
The generic ingredient in ZIRGAN 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 ZIRGAN 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 022211
| Tradename: | ZIRGAN |
| Applicant: | Bausch And Lomb |
| Ingredient: | ganciclovir |
| Patents: | 0 |
Pharmacology for NDA: 022211
| Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 022211
Suppliers and Packaging for NDA: 022211
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZIRGAN | ganciclovir | GEL;OPHTHALMIC | 022211 | NDA | Bausch & Lomb Incorporated | 24208-535 | 24208-535-15 | 1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-15) / 1.5 g in 1 TUBE, WITH APPLICATOR |
| ZIRGAN | ganciclovir | GEL;OPHTHALMIC | 022211 | NDA | Bausch & Lomb Incorporated | 24208-535 | 24208-535-35 | 1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-35) / 5 g in 1 TUBE, WITH APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;OPHTHALMIC | Strength | 0.15% | ||||
| Approval Date: | Sep 15, 2009 | TE: | RLD: | Yes | |||||
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