Details for New Drug Application (NDA): 202408
✉ Email this page to a colleague
NDA 202408 describes AVACLYR, which is a drug marketed by Fera Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the AVACLYR profile page.
The generic ingredient in AVACLYR is acyclovir. There are fifty-six drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the acyclovir profile page.
The generic ingredient in AVACLYR is acyclovir. There are fifty-six drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the acyclovir profile page.
Summary for 202408
| Tradename: | AVACLYR |
| Applicant: | Fera Pharms Llc |
| Ingredient: | acyclovir |
| Patents: | 0 |
Pharmacology for NDA: 202408
| Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 202408
Suppliers and Packaging for NDA: 202408
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AVACLYR | acyclovir | OINTMENT;OPHTHALMIC | 202408 | NDA | Fera Pharmaceuticals, LLC | 48102-028 | 48102-028-35 | 1 TUBE in 1 CARTON (48102-028-35) / 3.5 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | OINTMENT;OPHTHALMIC | Strength | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 29, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 29, 2026 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ACUTE HERPETIC KERATITIS (DENDRITIC ULCERS) IN PATIENTS WITH HERPES SIMPLEX (HSV-1 AND HSV-2) VIRUS | ||||||||
Complete Access Available with Subscription
