Details for New Drug Application (NDA): 212126
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The generic ingredient in ENTECAVIR is entecavir. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.
Summary for 212126
Tradename: | ENTECAVIR |
Applicant: | Brightgene |
Ingredient: | entecavir |
Patents: | 0 |
Pharmacology for NDA: 212126
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 212126
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ENTECAVIR | entecavir | TABLET;ORAL | 212126 | ANDA | EPIC PHARMA, LLC | 42806-658 | 42806-658-30 | 30 TABLET in 1 BOTTLE, PLASTIC (42806-658-30) |
ENTECAVIR | entecavir | TABLET;ORAL | 212126 | ANDA | EPIC PHARMA, LLC | 42806-659 | 42806-659-30 | 30 TABLET in 1 BOTTLE, PLASTIC (42806-659-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Sep 25, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Sep 25, 2019 | TE: | AB | RLD: | No |
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