Details for New Drug Application (NDA): 022272
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NDA 022272 describes OXYCONTIN, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from two suppliers. There are fifteen patents protecting this drug and seven Paragraph IV challenges. Additional details are available on the OXYCONTIN profile page.
The generic ingredient in OXYCONTIN is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.
The generic ingredient in OXYCONTIN is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.
Summary for 022272
| Tradename: | OXYCONTIN |
| Applicant: | Purdue Pharma Lp |
| Ingredient: | oxycodone hydrochloride |
| Patents: | 15 |
Pharmacology for NDA: 022272
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 022272
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272 | NDA | Purdue Pharma LP | 59011-410 | 59011-410-10 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59011-410-10) |
| OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272 | NDA | Purdue Pharma LP | 59011-410 | 59011-410-20 | 2 BLISTER PACK in 1 CARTON (59011-410-20) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 5, 2010 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Aug 24, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Aug 24, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Aug 24, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022272
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