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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 206986


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NDA 206986 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.
Summary for 206986
Tradename:HYDROCODONE BITARTRATE
Applicant:Alvogen
Ingredient:hydrocodone bitartrate
Patents:0
Pharmacology for NDA: 206986
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for 206986
Suppliers and Packaging for NDA: 206986
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 206986 ANDA Alvogen Inc. 47781-409 47781-409-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47781-409-60)
HYDROCODONE BITARTRATE hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 206986 ANDA Alvogen Inc. 47781-410 47781-410-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47781-410-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jan 21, 2020TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Jan 21, 2020TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jan 21, 2020TE:RLD:No

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