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Details for New Drug Application (NDA): 019909
NDA 019909 describes ZOVIRAX, which is a drug marketed by Mylan Pharms Inc, VIB, Glaxosmithkline, and Valeant Bermuda, and is included in six NDAs. It is available from six suppliers. Additional details are available on the ZOVIRAX profile page.
The generic ingredient in ZOVIRAX is acyclovir sodium. There are fifty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
The generic ingredient in ZOVIRAX is acyclovir sodium. There are fifty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 019909
| Tradename: | ZOVIRAX |
| Applicant: | Mylan Pharms Inc |
| Ingredient: | acyclovir |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019909
| Ingredient-type | Nucleoside Analog |
| Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 019909
Suppliers and Packaging for NDA: 019909
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZOVIRAX | acyclovir | SUSPENSION;ORAL | 019909 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-8712 | 0378-8712-73 | 473 mL in 1 BOTTLE (0378-8712-73) |
| ZOVIRAX | acyclovir | SUSPENSION;ORAL | 019909 | NDA | Mylan Pharmaceuticals Inc. | 0378-9735 | 0378-9735-73 | 473 mL in 1 BOTTLE (0378-9735-73) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 200MG/5ML | ||||
| Approval Date: | Dec 22, 1989 | TE: | AB | RLD: | Yes | ||||
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