Details for New Drug Application (NDA): 205510
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The generic ingredient in ACYCLOVIR is acyclovir sodium. There are fifty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 205510
Tradename: | ACYCLOVIR |
Applicant: | Glenmark Speclt |
Ingredient: | acyclovir |
Patents: | 0 |
Pharmacology for NDA: 205510
Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 205510
Suppliers and Packaging for NDA: 205510
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR | acyclovir | OINTMENT;TOPICAL | 205510 | ANDA | Northstar Rx LLC | 16714-885 | 16714-885-01 | 1 TUBE in 1 CARTON (16714-885-01) / 15 g in 1 TUBE |
ACYCLOVIR | acyclovir | OINTMENT;TOPICAL | 205510 | ANDA | Northstar Rx LLC | 16714-885 | 16714-885-02 | 1 TUBE in 1 CARTON (16714-885-02) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 5% | ||||
Approval Date: | Jul 31, 2017 | TE: | AB | RLD: | No |
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