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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084233
Company: INVATECH

Products on ANDA 084233

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084233

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/08/1985	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/17/1983	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.

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