Details for New Drug Application (NDA): 209385
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NDA 209385 describes OXYCODONE AND ACETAMINOPHEN, which is a drug marketed by Actavis Elizabeth, Barr, Duramed Pharms Barr, Halsey, Mallinckrodt, Mutual Pharm, Vintage Pharms, Vintage Pharms Llc, Watson Labs, Abhai Llc, Mikart, Nostrum Labs Inc, Specgx Llc, Alvogen, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell, Dr Reddys Labs Sa, Elite Labs Inc, Endo Operations, Epic Pharma Llc, Granules, Lannett Co Inc, Nesher Pharms, Novel Labs Inc, Rhodes Pharms, Sanaluz, Sun Pharm Inds Inc, and Wes Pharma Inc, and is included in fifty-one NDAs. It is available from thirty-five suppliers. Additional details are available on the OXYCODONE AND ACETAMINOPHEN profile page.
The generic ingredient in OXYCODONE AND ACETAMINOPHEN is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.
The generic ingredient in OXYCODONE AND ACETAMINOPHEN is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.
Summary for 209385
| Tradename: | OXYCODONE AND ACETAMINOPHEN |
| Applicant: | Elite Labs Inc |
| Ingredient: | acetaminophen; oxycodone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 209385
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 209385
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXYCODONE AND ACETAMINOPHEN | acetaminophen; oxycodone hydrochloride | TABLET;ORAL | 209385 | ANDA | Elite Laboratories, Inc. | 64850-621 | 64850-621-01 | 100 TABLET in 1 BOTTLE (64850-621-01) |
| OXYCODONE AND ACETAMINOPHEN | acetaminophen; oxycodone hydrochloride | TABLET;ORAL | 209385 | ANDA | Elite Laboratories, Inc. | 64850-622 | 64850-622-01 | 100 TABLET in 1 BOTTLE (64850-622-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;5MG | ||||
| Approval Date: | Jul 2, 2018 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;7.5MG | ||||
| Approval Date: | Jul 2, 2018 | TE: | AA | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;10MG | ||||
| Approval Date: | Jul 2, 2018 | TE: | AA | RLD: | No | ||||
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