APPLICATION
ANDA087513
TYPE
ANDA
ORIGINAL APPROVAL
1982-02-10
LATEST ACTION
2020-03-17
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Prescription
Products
DIPHENHYDRAMINE HYDROCHLORIDE · ReferencePrescription
DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML · ELIXIR · ORAL
Approval history
2020-03-17Manufacturing (CMC) · Supplement 14AP
2009-06-10Labeling · Supplement 12AP
1996-03-20Labeling · Supplement 10AP
1991-11-12Manufacturing (CMC) · Supplement 7AP
1990-11-21Labeling · Supplement 9AP
1990-04-12Labeling · Supplement 8AP
1988-09-14Labeling · Supplement 6AP
1988-07-25Labeling · Supplement 5AP
1987-09-09Manufacturing (CMC) · Supplement 3AP
1982-02-10OriginalAP
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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