Details for New Drug Application (NDA): 205469
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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 205469
Tradename: | ACYCLOVIR |
Applicant: | Taro |
Ingredient: | acyclovir |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205469
Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 205469
Suppliers and Packaging for NDA: 205469
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR | acyclovir | OINTMENT;TOPICAL | 205469 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-1360 | 51672-1360-1 | 1 TUBE in 1 CARTON (51672-1360-1) / 15 g in 1 TUBE |
ACYCLOVIR | acyclovir | OINTMENT;TOPICAL | 205469 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-1360 | 51672-1360-2 | 1 TUBE in 1 CARTON (51672-1360-2) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 5% | ||||
Approval Date: | Dec 21, 2016 | TE: | AB | RLD: | No |
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