APPLICATION
NDA010926
TYPE
NDA
ORIGINAL APPROVAL
1958-05-05
LATEST ACTION
2015-08-04
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued
Products
PHENERGAN · ReferenceDiscontinued
PROMETHAZINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUPPOSITORY · RECTAL
PHENERGAN · ReferenceDiscontinued
PROMETHAZINE HYDROCHLORIDE 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUPPOSITORY · RECTAL
Approval history
2015-08-04Manufacturing (CMC) · Supplement 31 · standardAP
2001-09-12Manufacturing (CMC) · Supplement 27 · standardAP
2001-07-27Manufacturing (CMC) · Supplement 19 · standardAP
2001-06-22Manufacturing (CMC) · Supplement 18 · standardAP
1994-07-01Manufacturing (CMC) · Supplement 16 · standardAP
1993-04-28Manufacturing (CMC) · Supplement 14 · standardAP
1992-03-30Manufacturing (CMC) · Supplement 15 · standardAP
1988-06-30Manufacturing (CMC) · Supplement 11 · standardAP
1988-01-22Labeling · Supplement 10AP
1986-05-29Manufacturing (CMC) · Supplement 7 · standardAP
1958-05-05Type 3 - New Dosage Form · 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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