Details for New Drug Application (NDA): 022569
The generic ingredient in LAZANDA is fentanyl citrate. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
Summary for 022569
| Tradename: | LAZANDA |
| Applicant: | Btcp Pharma |
| Ingredient: | fentanyl citrate |
| Patents: | 1 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY, METERED;NASAL | Strength | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 30, 2011 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 26, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY, METERED;NASAL | Strength | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 30, 2011 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 26, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY, METERED;NASAL | Strength | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 21, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 26, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022569
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-002 | Jun 30, 2011 | ⤷ Start Trial | ⤷ Start Trial |
| Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-001 | Jun 30, 2011 | ⤷ Start Trial | ⤷ Start Trial |
| Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-002 | Jun 30, 2011 | ⤷ Start Trial | ⤷ Start Trial |
| Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-002 | Jun 30, 2011 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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