FDA ANDA · ANDA084506

DIPHENHYDRAMINE HYDROCHLORIDE

Sponsor: MUTUAL PHARM

APPLICATION

ANDA084506

TYPE

ANDA

ORIGINAL APPROVAL

1974-12-19

LATEST ACTION

1998-12-01

ROUTE

ORAL

DOSAGE FORM

CAPSULE

MARKETING STATUS

Discontinued

Products

DIPHENHYDRAMINE HYDROCHLORIDEDiscontinued

DIPHENHYDRAMINE HYDROCHLORIDE 25MG · CAPSULE · ORAL

1998-12-01Manufacturing (CMC) · Supplement 58AP

1994-12-23Manufacturing (CMC) · Supplement 57AP

1994-10-11Manufacturing (CMC) · Supplement 56AP

1992-04-03Manufacturing (CMC) · Supplement 55AP

1992-04-03Manufacturing (CMC) · Supplement 53AP

1988-04-21Labeling · Supplement 52AP

1987-03-20Manufacturing (CMC) · Supplement 50AP

1986-02-11Manufacturing (CMC) · Supplement 48AP

1986-02-11Manufacturing (CMC) · Supplement 47AP

1983-03-31Manufacturing (CMC) · Supplement 41AP

1974-12-19OriginalAP

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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