Details for New Drug Application (NDA): 218623
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The generic ingredient in LIBERVANT is diazepam. There are eight drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the diazepam profile page.
Suppliers and Packaging for NDA: 218623
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LIBERVANT | diazepam | FILM;BUCCAL | 218623 | NDA | AQUESTIVE THERAPEUTICS | 10094-305 | 10094-305-02 | 2 POUCH in 1 BOX (10094-305-02) / 1 FILM in 1 POUCH (10094-305-01) |
LIBERVANT | diazepam | FILM;BUCCAL | 218623 | NDA | AQUESTIVE THERAPEUTICS | 10094-307 | 10094-307-02 | 2 POUCH in 1 BOX (10094-307-02) / 1 FILM in 1 POUCH (10094-307-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;BUCCAL | Strength | 5MG | ||||
Approval Date: | Apr 26, 2024 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Apr 26, 2027 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 18, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;BUCCAL | Strength | 7.5MG | ||||
Approval Date: | Apr 26, 2024 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Apr 26, 2027 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT |
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