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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.

OXYCODONE HYDROCHLORIDE

ANDA

Tentative Approval

OXYCODONE HYDROCHLORIDE | A076610 | TEVA

API Supply Chain5 active DMFs6 inactive

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

SPECGX LLCOXYCODONE HYDROCHLORIDE USP (D)

DMF 69301987

NORAMCO LLCOXYCODONE HYDROCHLORIDE

DMF 163992003

VERANOVA LPOXYCODONE HYDROCHLORIDE

DMF 184722005

NORAMCO LLCOXYCODONE HYDROCHLORIDE DRUG SUBSTANCE

DMF 209752007

SIEGFRIED USA LLCOXYCODONE HYDROCHLORIDE USP

DMF 235202010

MALLINCKRODT CHEMICAL INCInactiveOXYCODONE HYDROCHLORIDE PURIFIED RECRYSTALLIZED

DMF 28211977

NORAMCO INCInactiveOXYCODONE HYDROCHLORIDE

DMF 63181986

PENICK CORPInactiveOXYCODONE HYDROCHLORIDE

DMF 67681987

SIEGFRIED USA INCInactiveOXYCODONE HYDROCHLORIDE USP

DMF 193962006

JOHNSON MATTHEY PHARMACEUTICAL MATERIALSInactiveOXYCODONE HYDROCHLORIDE (MS PROCESS)

DMF 207292007

NORAMCO LLCInactiveOXYCODONE HYDROCHLORIDE USP (PROCESS II)

DMF 313772018

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 23, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MG

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TABLET, EXTENDED RELEASE; ORAL | TA Date: 2004-12-09 00:00:00

No patent or exclusivity listings for this strength.

#002 — 20MG

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TABLET, EXTENDED RELEASE; ORAL | TA Date: 2004-12-09 00:00:00

#003 — 40MG

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TABLET, EXTENDED RELEASE; ORAL | TA Date: 2004-12-09 00:00:00