APPLICATION
NDA007935
TYPE
NDA
ORIGINAL APPROVAL
1951-03-29
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PHENERGAN · ReferenceDiscontinued
PROMETHAZINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PHENERGAN · ReferenceDiscontinued
PROMETHAZINE HYDROCHLORIDE 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PHENERGAN · ReferenceDiscontinued
PROMETHAZINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2009-03-13Labeling · Supplement 6AP
2009-03-13Labeling · Supplement 4AP
2009-03-13Labeling · Supplement 23AP
2009-03-13Labeling · Supplement 13AP
2009-03-13Labeling · Supplement 9AP
2009-03-13Labeling · Supplement 7AP
2009-03-13Labeling · Supplement 29 · standardAP
1992-03-30Manufacturing (CMC) · Supplement 24 · standardAP
1989-12-11Manufacturing (CMC) · Supplement 16 · standardAP
1989-11-21Manufacturing (CMC) · Supplement 21 · standardAP
1988-06-30Manufacturing (CMC) · Supplement 22 · standardAP
1988-05-31Manufacturing (CMC) · Supplement 18 · standardAP
1988-04-07Labeling · Supplement 20AP
1988-01-22Labeling · Supplement 19AP
1987-03-19Manufacturing (CMC) · Supplement 14 · standardAP
1986-05-29Manufacturing (CMC) · Supplement 12 · 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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