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Details for New Drug Application (NDA): 201013
NDA 201013 describes HYDROCODONE BITARTRATE AND ACETAMINOPHEN, which is a drug marketed by Mallinckrodt, Mikart, Mallinckrodt Inc, Nesher Pharms, Pharm Assoc, Vintage Pharms, Vistapharm, Abhai Llc, Able, Actavis Labs Fl Inc, Amneal Pharms, Amneal Pharms Ny, Apil, Aurolife Pharma Llc, Barr, Caraco, Epic Pharma Llc, Halsey, Ivax Pharms, Lannett Holdings Inc, Larken Labs Inc, Mutual Pharm, Novel Labs Inc, Par Pharm, Ranbaxy, Ranbaxy Labs Ltd, Rhodes Pharms, Sandoz, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Tris Pharma Inc, Ucb Inc, Upsher-smith Labs, Usl Pharma, Vintage Pharms Llc, Watson Labs, Watson Labs Florida, and Wes Pharma Inc, and is included in one hundred and fifteen NDAs. It is available from seventy-seven 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. Seventy-seven 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. Seventy-seven suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 201013
| Tradename: | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| Applicant: | Aurolife Pharma Llc |
| Ingredient: | acetaminophen; hydrocodone bitartrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201013
| Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 201013
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 201013 | ANDA | Aurolife Pharma LLC | 13107-019 | N | 13107-019-01 |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 201013 | ANDA | Aurolife Pharma LLC | 13107-019 | N | 13107-019-05 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;5MG | ||||
| Approval Date: | Apr 11, 2012 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;7.5MG | ||||
| Approval Date: | Apr 11, 2012 | TE: | AA | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;10MG | ||||
| Approval Date: | Apr 11, 2012 | TE: | AA | RLD: | No | ||||
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