Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083997
Company: ALTANA

Products on ANDA 083997

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083997

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/1978	ORIG-1	Approval				Label is not available on this site.