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ORPHENADRINE CITRATE

ANDA

ORPHENADRINE CITRATE | A040368 | JEROME STEVENS PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs3 inactive

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

W R GRACE AND CO -CONNORPHENADRINE CITRATE USP

DMF 57221985

PROCOS SPAORPHENADRINE CITRATE

DMF 149712000

R L FINE CHEM PVT LTDORPHENADRINE CITRATE

DMF 339012019

R L FINE CHEM PVT LTDORPHENADRINE CITRATE

DMF 384562023

ORGAMOL SAInactiveORPHENADRINE CITRATE AND ORPHENADRINE HCL.

DMF 48111983

3M PHARMACEUTICALSInactiveORPHENADRINE CITRATE

DMF 71081987

IROPHARM LTDInactiveORPHENADRINE CITRATE

DMF 78371988

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 23, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 23, 2000

No patent or exclusivity listings for this strength.