Details for New Drug Application (NDA): 208082
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NDA 208082 describes AUSTEDO, which is a drug marketed by Teva Branded Pharm and Teva and is included in two NDAs. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the AUSTEDO profile page.
The generic ingredient in AUSTEDO is deutetrabenazine. One supplier is listed for this compound. Additional details are available on the deutetrabenazine profile page.
The generic ingredient in AUSTEDO is deutetrabenazine. One supplier is listed for this compound. Additional details are available on the deutetrabenazine profile page.
Summary for 208082
| Tradename: | AUSTEDO |
| Applicant: | Teva Branded Pharm |
| Ingredient: | deutetrabenazine |
| Patents: | 14 |
Suppliers and Packaging for NDA: 208082
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082 | NDA | Teva Neuroscience, Inc. | 68546-170 | 68546-170-60 | 60 TABLET, COATED in 1 BOTTLE (68546-170-60) |
| AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082 | NDA | Teva Neuroscience, Inc. | 68546-171 | 68546-171-60 | 60 TABLET, COATED in 1 BOTTLE (68546-171-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
| Approval Date: | Apr 3, 2017 | TE: | RLD: | Yes | |||||
| Patent: | 10,959,996*PED | Patent Expiration: | Sep 7, 2036 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 11,179,386*PED | Patent Expiration: | Sep 15, 2038 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 11,357,772*PED | Patent Expiration: | Sep 7, 2036 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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