Details for New Drug Application (NDA): 206770
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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 206770
Tradename: | ACYCLOVIR |
Applicant: | Zydus Lifesciences |
Ingredient: | acyclovir |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206770
Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 206770
Suppliers and Packaging for NDA: 206770
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR | acyclovir | CREAM;TOPICAL | 206770 | ANDA | Zydus Lifesciences Limited | 70771-1808 | 70771-1808-2 | 1 TUBE in 1 CARTON (70771-1808-2) / 2 g in 1 TUBE |
ACYCLOVIR | acyclovir | CREAM;TOPICAL | 206770 | ANDA | Zydus Lifesciences Limited | 70771-1808 | 70771-1808-5 | 1 TUBE in 1 CARTON (70771-1808-5) / 5 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 5% | ||||
Approval Date: | Feb 28, 2023 | TE: | AB | RLD: | No |
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