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FDA ANDA · ANDA209177

PROMETHAZINE HYDROCHLORIDE

Sponsor: STRIDES PHARMA

APPLICATION
ANDA209177
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-30
LATEST ACTION
2017-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROMETHAZINE HYDROCHLORIDEDiscontinued
PROMETHAZINE HYDROCHLORIDE 50MG · TABLET · ORAL
PROMETHAZINE HYDROCHLORIDEDiscontinued
PROMETHAZINE HYDROCHLORIDE 12.5MG · TABLET · ORAL
PROMETHAZINE HYDROCHLORIDEDiscontinued
PROMETHAZINE HYDROCHLORIDE 25MG · TABLET · ORAL

Approval history

2017-06-30UNKNOWN · Original · standardAP
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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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