Details for New Drug Application (NDA): 209366
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The generic ingredient in ACYCLOVIR is acyclovir sodium. There are fifty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 209366
Tradename: | ACYCLOVIR |
Applicant: | Square Pharms |
Ingredient: | acyclovir |
Patents: | 0 |
Pharmacology for NDA: 209366
Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 209366
Suppliers and Packaging for NDA: 209366
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR | acyclovir | TABLET;ORAL | 209366 | ANDA | A-S Medication Solutions | 50090-6335 | 50090-6335-0 | 35 TABLET in 1 BOTTLE (50090-6335-0) |
ACYCLOVIR | acyclovir | TABLET;ORAL | 209366 | ANDA | A-S Medication Solutions | 50090-6335 | 50090-6335-2 | 70 TABLET in 1 BOTTLE (50090-6335-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | Oct 7, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | Oct 7, 2019 | TE: | AB | RLD: | No |
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