Details for New Drug Application (NDA): 208269
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NDA 208269 describes HYDROCODONE BITARTRATE, which is a drug marketed by Alvogen, 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, 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, Watson Labs Florida, Lgm Pharma, Acella, Actavis Mid Atlantic, Ivax Sub Teva Pharms, Nostrum Labs Inc, Padagis Us, Sciegen Pharms Inc, Wockhardt Bio Ag, Ani Pharms, Teva, and Mayne Pharma Inc, and is included in one hundred and fifty-five NDAs. It is available from one supplier. Additional details are available on the HYDROCODONE BITARTRATE profile page.
The generic ingredient in HYDROCODONE BITARTRATE is chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride. There are twenty-nine drug master file entries for this compound. Additional details are available on the chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride profile page.
The generic ingredient in HYDROCODONE BITARTRATE is chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride. There are twenty-nine drug master file entries for this compound. Additional details are available on the chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride profile page.
Summary for 208269
| Tradename: | HYDROCODONE BITARTRATE |
| Applicant: | Alvogen |
| Ingredient: | hydrocodone bitartrate |
| Patents: | 0 |
Pharmacology for NDA: 208269
| Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 208269
Suppliers and Packaging for NDA: 208269
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 208269 | ANDA | Alvogen Inc. | 47781-392 | 47781-392-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-392-60) |
| HYDROCODONE BITARTRATE | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 208269 | ANDA | Alvogen Inc. | 47781-393 | 47781-393-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-393-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 20MG | ||||
| Approval Date: | Mar 1, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
| Approval Date: | Mar 1, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 40MG | ||||
| Approval Date: | Mar 1, 2021 | TE: | AB | RLD: | No | ||||
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