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OXYCODONE HYDROCHLORIDE

NDA

OXYCODONE HYDROCHLORIDE | N201194 | VISTAPHARM LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

12 letters from Drugs@FDA

Date	Submission	Document
Jun 23, 2026	SUPPL -22	View Letter (PDF)
Dec 29, 2025	SUPPL -21	View Letter (PDF)
Nov 4, 2024	SUPPL -20	View Letter (PDF)
Apr 22, 2024	SUPPL -19	View Letter (PDF)
Dec 19, 2023	SUPPL -17	View Letter (PDF)
Jul 22, 2021	SUPPL -9	View Letter (PDF)
Mar 8, 2021	SUPPL -10	View Letter (PDF)
Oct 9, 2019	SUPPL -8	View Letter (PDF)
Oct 1, 2018	SUPPL -4	View Letter (PDF)
Oct 1, 2018	SUPPL -3	View Letter (PDF)
Dec 21, 2016	SUPPL -2	View Letter (PDF)
Jan 17, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Jan 12, 2012

No patent or exclusivity listings for this strength.