Details for New Drug Application (NDA): 022411
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The generic ingredient in OLEPTRO is trazodone hydrochloride. There are fourteen drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.
Summary for 022411
Tradename: | OLEPTRO |
Applicant: | Angelini Pharma |
Ingredient: | trazodone hydrochloride |
Patents: | 2 |
Medical Subject Heading (MeSH) Categories for 022411
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 2, 2010 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 27, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF TREATING DEPRESSION | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 13, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 2, 2010 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 27, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF TREATING DEPRESSION |
Expired US Patents for NDA 022411
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Angelini Pharma | OLEPTRO | trazodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022411-001 | Feb 2, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Angelini Pharma | OLEPTRO | trazodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022411-002 | Feb 2, 2010 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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