Details for New Drug Application (NDA): 204605
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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 204605
Tradename: | ACYCLOVIR |
Applicant: | Amneal Pharms |
Ingredient: | acyclovir |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204605
Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 204605
Suppliers and Packaging for NDA: 204605
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR | acyclovir | OINTMENT;TOPICAL | 204605 | ANDA | Amneal Pharmaceuticals LLC | 65162-835 | 65162-835-94 | 1 TUBE in 1 CARTON (65162-835-94) / 15 g in 1 TUBE |
ACYCLOVIR | acyclovir | OINTMENT;TOPICAL | 204605 | ANDA | Amneal Pharmaceuticals LLC | 65162-835 | 65162-835-96 | 1 TUBE in 1 CARTON (65162-835-96) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 5% | ||||
Approval Date: | Jun 18, 2014 | TE: | AB | RLD: | No |
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