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Details for New Drug Application (NDA): 204314
The generic ingredient in ACYCLOVIR is acyclovir sodium. There are fifty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 204314
Tradename: | ACYCLOVIR |
Applicant: | Zydus Pharms Usa Inc |
Ingredient: | acyclovir |
Patents: | 0 |
Therapeutic Class: | Antivirals |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204314
Ingredient-type | Nucleoside Analog |
Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 204314
Suppliers and Packaging for NDA: 204314
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR | acyclovir | TABLET;ORAL | 204314 | ANDA | Unit Dose Services | 50436-0792 | N | 50436-0792-1 |
ACYCLOVIR | acyclovir | TABLET;ORAL | 204314 | ANDA | Aidarex Pharmaceuticals LLC | 53217-188 | N | 53217-188-25 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | Aug 19, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | Aug 19, 2014 | TE: | AB | RLD: | No |
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