APPLICATION
ANDA083088
TYPE
ANDA
ORIGINAL APPROVAL
1973-01-12
LATEST ACTION
1985-08-12
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued
Products
DIPHENHYDRAMINE HYDROCHLORIDEDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML · ELIXIR · ORAL
Approval history
1985-08-12Manufacturing (CMC) · Supplement 12AP
1982-10-29Manufacturing (CMC) · Supplement 10AP
1973-01-12OriginalAP
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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