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OXYMORPHONE HYDROCHLORIDE

ANDA

OXYMORPHONE HYDROCHLORIDE | A202321 | SPECGX LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain2 active DMFs4 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SPECGX LLCOXYMORPHONE HYDROCHLORIDE USP

DMF 145021999

NORAMCO LLCOXYMORPHONE HYDROCHLORIDE DRUG SUBSTANCE

DMF 228162009

DIOSYNTH INCInactiveOXYMORPHONE HYDROCHLORIDE

DMF 74511988

MALLINCKRODT CHEMICAL INCInactiveOXYMORPHONE HYDROCHLORIDE

DMF 91091991

SIEGFRIED USA INCInactiveOXYMORPHONE HYDROCHLORIDE USP

DMF 234032009

SIEGFRIED USA LLCInactiveOXYMORPHONE HYDROCHLORIDE USP (LOW ABUK IMPURITY)

DMF 256282011

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

Products (2)

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#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 25, 2013

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 25, 2013