Details for New Drug Application (NDA): 214826
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NDA 214826 describes LOREEV XR, which is a drug marketed by Almatica and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the LOREEV XR profile page.
The generic ingredient in LOREEV XR is lorazepam. There are eleven drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the lorazepam profile page.
The generic ingredient in LOREEV XR is lorazepam. There are eleven drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the lorazepam profile page.
Summary for 214826
| Tradename: | LOREEV XR |
| Applicant: | Almatica |
| Ingredient: | lorazepam |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 214826
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOREEV XR | lorazepam | CAPSULE, EXTENDED RELEASE;ORAL | 214826 | NDA | Almatica Pharma LLC | 52427-658 | 52427-658-30 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-658-30) |
| LOREEV XR | lorazepam | CAPSULE, EXTENDED RELEASE;ORAL | 214826 | NDA | Almatica Pharma LLC | 52427-661 | 52427-661-30 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-661-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 1MG | ||||
| Approval Date: | Aug 27, 2021 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 8, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ONCE DAILY TREATMENT OF ANXIETY DISORDER IN ADULTS | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 2MG | ||||
| Approval Date: | Aug 27, 2021 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 8, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ONCE DAILY TREATMENT OF ANXIETY DISORDER IN ADULTS | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 3MG | ||||
| Approval Date: | Aug 27, 2021 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 8, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ONCE DAILY TREATMENT OF ANXIETY DISORDER IN ADULTS | ||||||||
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