Details for New Drug Application (NDA): 019909
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The generic ingredient in ZOVIRAX is acyclovir sodium. There are fifty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 019909
Tradename: | ZOVIRAX |
Applicant: | Mylan |
Ingredient: | acyclovir |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019909
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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