Details for New Drug Application (NDA): 206745
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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 206745
Tradename: | ENTECAVIR |
Applicant: | Zydus Pharms |
Ingredient: | entecavir |
Patents: | 0 |
Pharmacology for NDA: 206745
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 206745
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ENTECAVIR | entecavir | TABLET;ORAL | 206745 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-920 | 68382-920-01 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-920-01) |
ENTECAVIR | entecavir | TABLET;ORAL | 206745 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-920 | 68382-920-06 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-920-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Jun 23, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Jun 23, 2017 | TE: | AB | RLD: | No |
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