Details for New Drug Application (NDA): 204313
✉ Email this page to a colleague
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 204313
Tradename: | ACYCLOVIR |
Applicant: | Cadila |
Ingredient: | acyclovir |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204313
Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 204313
Suppliers and Packaging for NDA: 204313
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR | acyclovir | CAPSULE;ORAL | 204313 | ANDA | Northwind Pharmaceuticals, LLC | 51655-965 | 51655-965-52 | 30 CAPSULE in 1 BOTTLE, PLASTIC (51655-965-52) |
ACYCLOVIR | acyclovir | CAPSULE;ORAL | 204313 | ANDA | RPK Pharmaceuticals, Inc. | 53002-2452 | 53002-2452-1 | 25 CAPSULE in 1 BOTTLE (53002-2452-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Mar 25, 2016 | TE: | AB | RLD: | No |
Complete Access Available with Subscription