Details for New Drug Application (NDA): 022569
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NDA 022569 describes LAZANDA, which is a drug marketed by Btcp Pharma and is included in one NDA. There are five patents protecting this drug. Additional details are available on the LAZANDA profile page.
The generic ingredient in LAZANDA is fentanyl citrate. There are thirty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
The generic ingredient in LAZANDA is fentanyl citrate. There are thirty-one drug master file entries for this compound. Ten 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: | 5 |
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| SPRAY, METERED;NASAL | Strength | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | ⤷ Sign Up | Patent Expiration: | Oct 3, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 16, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 8, 2024 | 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 | 022569-001 | Jun 30, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-002 | Jun 30, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-001 | Jun 30, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-001 | Jun 30, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-002 | Jun 30, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-002 | Jun 30, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-001 | Jun 30, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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