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FDA ANDA · ANDA040284

ORPHENADRINE CITRATE

Sponsor: LUPIN

APPLICATION
ANDA040284
TYPE
ANDA
ORIGINAL APPROVAL
1998-06-19
LATEST ACTION
2024-08-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ORPHENADRINE CITRATEPrescription
ORPHENADRINE CITRATE 100MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-08-14Manufacturing (CMC) · Supplement 25 · unknownAP
2014-01-28Labeling · Supplement 21 · standardAP
2009-04-27Labeling · Supplement 19AP
2002-10-08Manufacturing (CMC) · Supplement 9AP
2002-10-08Manufacturing (CMC) · Supplement 11AP
2002-10-08Manufacturing (CMC) · Supplement 8AP
2002-10-08Manufacturing (CMC) · Supplement 10AP
2002-07-24Manufacturing (CMC) · Supplement 5AP
2002-07-24Manufacturing (CMC) · Supplement 4AP
2002-03-22Manufacturing (CMC) · Supplement 7AP
2002-03-22Manufacturing (CMC) · Supplement 6AP
1998-06-19Original — Letter ↗AP
1998-06-19Manufacturing (CMC) · Supplement 1AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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