Details for New Drug Application (NDA): 203863
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NDA 203863 describes HYDROCODONE BITARTRATE AND ACETAMINOPHEN, which is a drug marketed by Mallinckrodt, Mikart, Chartwell, Genus, Mallinckrodt Inc, Nesher Pharms, Pharm Assoc, Tris Pharma Inc, Vintage Pharms, Wes Pharma Inc, Abhai Llc, Able, Actavis Labs Fl Inc, Alvogen, Amneal Pharms, Amneal Pharms Ny, Apil, Ascent Pharms Inc, Aurolife Pharma Llc, Barr, Caraco, Elite Labs Inc, Endo Operations, Epic Pharma Llc, Granules, Halsey, Ivax Pharms, Lannett Co Inc, Mutual Pharm, Novel Labs Inc, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Rhodes Pharms, Sanaluz, Sandoz, Specgx Llc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Ucb Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms Llc, Watson Labs, and Watson Labs Florida, and is included in one hundred and twenty-six NDAs. It is available from thirty-eight suppliers. Additional details are available on the HYDROCODONE BITARTRATE AND ACETAMINOPHEN profile page.
The generic ingredient in HYDROCODONE BITARTRATE AND ACETAMINOPHEN is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
The generic ingredient in HYDROCODONE BITARTRATE AND ACETAMINOPHEN is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 203863
| Tradename: | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| Applicant: | Epic Pharma Llc |
| Ingredient: | acetaminophen; hydrocodone bitartrate |
| Patents: | 0 |
Pharmacology for NDA: 203863
| Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 203863
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 203863 | ANDA | Epic Pharma, LLC | 42806-111 | 42806-111-01 | 100 TABLET in 1 BOTTLE (42806-111-01) |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 203863 | ANDA | Epic Pharma, LLC | 42806-112 | 42806-112-01 | 100 TABLET in 1 BOTTLE (42806-112-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;5MG | ||||
| Approval Date: | Mar 30, 2018 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;7.5MG | ||||
| Approval Date: | Mar 30, 2018 | TE: | AA | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;10MG | ||||
| Approval Date: | Mar 30, 2018 | TE: | AA | RLD: | No | ||||
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