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FDA ANDA · ANDA090775

DULOXETINE HYDROCHLORIDE

Sponsor: SANDOZ

APPLICATION
ANDA090775
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
None (Tentative Approval)

Products

DULOXETINE HYDROCHLORIDENone (Tentative Approval)
DULOXETINE HYDROCHLORIDE 30MG · CAPSULE, DELAYED RELEASE · ORAL
DULOXETINE HYDROCHLORIDENone (Tentative Approval)
DULOXETINE HYDROCHLORIDE 60MG · CAPSULE, DELAYED RELEASE · ORAL
DULOXETINE HYDROCHLORIDENone (Tentative Approval)
DULOXETINE HYDROCHLORIDE 20MG · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2011-02-02OriginalTA
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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