Details for New Drug Application (NDA): 200535
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NDA 200535 describes OXYCODONE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Avanthi Inc, Dr Reddys Labs Sa, Genus Lifesciences, Lannett Co Inc, Novel Labs Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell Molecular, Hikma, Pharm Assoc, Quagen, Rhodes Pharms, Specgx Llc, Vistapharm, Vistapharm Llc, Wes Pharma Inc, Xttrium Labs Inc, Actavis Elizabeth, Alvogen, Amneal Pharms, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Strides Pharma, Sun Pharm Inds Inc, Endo Operations, Barr Labs Inc, and Watson Labs, and is included in fifty-one NDAs. It is available from thirty-seven suppliers. Additional details are available on the OXYCODONE HYDROCHLORIDE profile page.
The generic ingredient in OXYCODONE HYDROCHLORIDE is ibuprofen; oxycodone hydrochloride. There are sixty-four drug master file entries for this compound. Additional details are available on the ibuprofen; oxycodone hydrochloride profile page.
The generic ingredient in OXYCODONE HYDROCHLORIDE is ibuprofen; oxycodone hydrochloride. There are sixty-four drug master file entries for this compound. Additional details are available on the ibuprofen; oxycodone hydrochloride profile page.
Summary for 200535
| Tradename: | OXYCODONE HYDROCHLORIDE |
| Applicant: | Genus Lifesciences |
| Ingredient: | oxycodone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 200535
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 200535
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 200535 | NDA | Genus Lifesciences Inc. | 64950-353 | 64950-353-03 | 1 BOTTLE, PLASTIC in 1 CARTON (64950-353-03) / 30 mL in 1 BOTTLE, PLASTIC |
| OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 200535 | NDA | Genus Lifesciences Inc. | 64950-353 | 64950-353-51 | 50 POUCH in 1 CASE (64950-353-51) / 5 SYRINGE, PLASTIC in 1 POUCH (64950-353-91) / .5 mL in 1 SYRINGE, PLASTIC (64950-353-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 100MG/5ML | ||||
| Approval Date: | Oct 20, 2010 | TE: | AA | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jul 21, 2024 | ||||||||
| Regulatory Exclusivity Use: | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | Aug 22, 2013 | TE: | AA | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jul 21, 2024 | ||||||||
| Regulatory Exclusivity Use: | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | ||||||||
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