Details for New Drug Application (NDA): 202080
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The generic ingredient in OXAYDO is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.
Summary for 202080
Tradename: | OXAYDO |
Applicant: | Zyla |
Ingredient: | oxycodone hydrochloride |
Patents: | 2 |
Pharmacology for NDA: 202080
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 202080
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080 | NDA | Zyla Life Sciences US LLC | 69344-113 | 69344-113-11 | 100 TABLET in 1 BOTTLE (69344-113-11) |
OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080 | NDA | Zyla Life Sciences US LLC | 69344-213 | 69344-213-11 | 100 TABLET in 1 BOTTLE (69344-213-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jun 17, 2011 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 16, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | May 26, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
Approval Date: | Jun 17, 2011 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 16, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 202080
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-002 | Jun 17, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-002 | Jun 17, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-001 | Jun 17, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-001 | Jun 17, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-001 | Jun 17, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-002 | Jun 17, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-001 | Jun 17, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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