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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

MORPHINE SULFATE

ANDANot in Orange Book

MORPHINE SULFATE | A213892 | QUAGEN

API Supply Chain4 active DMFs6 inactive

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

SPECGX LLCMORPHINE SULFATE

DMF 58571985

NORAMCO LLCMORPHINE SULFATE

DMF 69671987

VERANOVA LPMORPHINE SULFATE USP

DMF 215882008

NORAMCO LLCMORPHINE SULFATE, USP

DMF 293172015

PENICK CORPInactiveMORPHINE SULFATE

DMF 66801986

MACFARLAN SMITH LTDInactiveMORPHINE SULFATE

DMF 83281989

MALLINCKRODT INCInactiveMORPHINE SULFATE INJECTION USP

DMF 115291995

ELAN PHARMA LTDInactiveMORPHINE SULFATE

DMF 128081997

SIEGFRIED USA LLCInactiveMORPHINE SULFATE USP

DMF 196932006

CODY LABORATORIES INCInactiveMORPHINE SULFATE, USP

DMF 280402014

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

Products (3)

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#001 — 10MG/5ML

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SOLUTION;ORAL | Approved: Jul. 7, 2026

No patent or exclusivity listings for this strength.

#002 — 20MG/5ML

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SOLUTION;ORAL | Approved: Jul. 7, 2026

#003 — 100MG/5ML

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SOLUTION;ORAL | Approved: Jul. 7, 2026