FDA NDA · NDA009818

KEMADRIN

Sponsor: MONARCH PHARMS

APPLICATION

NDA009818

TYPE

NDA

ORIGINAL APPROVAL

1955-07-27

LATEST ACTION

2011-07-01

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

KEMADRINDiscontinued

PROCYCLIDINE HYDROCHLORIDE 2MG · TABLET · ORAL

KEMADRINDiscontinued

PROCYCLIDINE HYDROCHLORIDE 5MG · TABLET · ORAL

2011-07-01Labeling · Supplement 18 · standard — Label ↗AP

1982-09-03Manufacturing (CMC) · Supplement 15 · standardAP

1980-02-19Manufacturing (CMC) · Supplement 13 · standardAP

1979-06-14Manufacturing (CMC) · Supplement 11 · standardAP

1978-04-10Manufacturing (CMC) · Supplement 9 · standardAP

1978-04-10Manufacturing (CMC) · Supplement 10 · standardAP

1977-02-09Manufacturing (CMC) · Supplement 8 · standardAP

1976-09-27Manufacturing (CMC) · Supplement 7 · standardAP

1974-11-25Manufacturing (CMC) · Supplement 6 · standardAP

1955-07-27Type 1 - New Molecular Entity · Original · standardAP

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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