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OXYCODONE HYDROCHLORIDE

ANDA

OXYCODONE HYDROCHLORIDE | A202662 | EPIC PHARMA LLC

5 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ROXICODONE(TE code: AB)

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
Sep 24, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 22, 2015

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 22, 2015

#003 — 15MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 22, 2015

#004 — 30MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 22, 2015

#005 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 27, 2017