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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010349
Company: HIKMA

Products on NDA 010349

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPARINE	PROMAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
SPARINE	PROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010349

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/13/1956	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

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