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FDA ANDA · ANDA205267

MILNACIPRAN HYDROCHLORIDE

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA205267
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

MILNACIPRAN HYDROCHLORIDENone (Tentative Approval)
MILNACIPRAN HYDROCHLORIDE 50MG · TABLET · ORAL
MILNACIPRAN HYDROCHLORIDENone (Tentative Approval)
MILNACIPRAN HYDROCHLORIDE 100MG · TABLET · ORAL
MILNACIPRAN HYDROCHLORIDENone (Tentative Approval)
MILNACIPRAN HYDROCHLORIDE 25MG · TABLET · ORAL

Approval history

2017-03-30UNKNOWN · Original · standardTA
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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