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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

HYDROCODONE BITARTRATE

ANDA

Tentative Approval

HYDROCODONE BITARTRATE | A206952 | ACTAVIS LABS FL INC

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Recro Gainesville LLC v. Actavis Laboratories FL, Inc. 1:2017cv01535 4 patentsANDA 206952hydrocodone bitartrate	D. Del.	2017-10-30	Terminated 2018-01-29	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain6 active DMFs5 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED USA LLCHYDROCODONE BITARTRATE USP

DMF 194602006

VERANOVA LPHYDROCODONE BITARTRATE USP

DMF 198482006

NORAMCO LLCHYDROCODONE BITARTRATE DRUG SUBSTANCE

DMF 211582007

CHATTEM CHEMICALS INCHYDROCODONE BITARTRATE USP

DMF 252852015

SPECGX LLCHYDROCODONE BITARTRATE USP CRYSTALS (NP)

DMF 259612013

CAMBREX CHARLES CITY INCHYDROCODONE BITARTRATE HEMIPENTAHYDRATE

DMF 293712015

SPECGX LLCInactiveHYDROCODONE BITARTRATE USP CRYSTALS

DMF 48841983

PENCO OF LYNDHURST INCInactiveHYDROCODONE BITARTRATE POWDER

DMF 58911985

NORAMCO INCInactiveHYDROCODONE BITARTRATE

DMF 70781987

WATSON LABORATORIES INCInactiveHYDROCODONE BITARTRATE TABLETS, 10 MG

DMF 120291996

WATSON LABORATORIES INCInactiveHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, 10 MG\650 MG

DMF 120251996

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

Sort:

#001 — 10MG

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CAPSULE, EXTENDED RELEASE; ORAL | TA Date: 2017-04-05 00:00:00

No patent or exclusivity listings for this strength.

#005 — 40MG

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CAPSULE, EXTENDED RELEASE;ORAL | TA Date: 2017-04-05 00:00:00