Details for New Drug Application (NDA): 206627
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NDA 206627 describes HYSINGLA ER, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from one supplier. There are twenty patents protecting this drug and two Paragraph IV challenges. Additional details are available on the HYSINGLA ER profile page.
The generic ingredient in HYSINGLA ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.
The generic ingredient in HYSINGLA ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.
Summary for 206627
| Tradename: | HYSINGLA ER |
| Applicant: | Purdue Pharma Lp |
| Ingredient: | hydrocodone bitartrate |
| Patents: | 20 |
Pharmacology for NDA: 206627
| Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 206627
Suppliers and Packaging for NDA: 206627
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627 | NDA | Purdue Pharma LP | 59011-271 | 59011-271-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-271-60) |
| HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627 | NDA | Purdue Pharma LP | 59011-272 | 59011-272-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-272-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 20MG | ||||
| Approval Date: | Nov 20, 2014 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 24, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | 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: | ⤷ Sign Up | Patent Expiration: | Feb 13, 2025 | Product Flag? | Y | 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 | ||||||||
Expired US Patents for NDA 206627
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