Details for New Drug Application (NDA): 216331
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The generic ingredient in ACYCLOVIR is acyclovir sodium. There are fifty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 216331
Tradename: | ACYCLOVIR |
Applicant: | Aurobindo Pharma |
Ingredient: | acyclovir |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216331
Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 216331
Suppliers and Packaging for NDA: 216331
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR | acyclovir | SUSPENSION;ORAL | 216331 | ANDA | Aurobindo Pharma Limited | 59651-493 | 59651-493-47 | 473 mL in 1 BOTTLE (59651-493-47) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 200MG/5ML | ||||
Approval Date: | Mar 31, 2022 | TE: | AB | RLD: | No |
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