← FDA DRUG APPROVALS
FDA ANDA · ANDA040428
PROMETHEGAN
promethazine hydrochloride
Sponsor: COSETTE PHARMS NC
APPLICATION
ANDA040428
TYPE
ANDA
ORIGINAL APPROVAL
2002-02-05
LATEST ACTION
2016-09-02
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Prescription
Products
PROMETHAZINE HYDROCHLORIDEPrescription
PROMETHAZINE HYDROCHLORIDE 25MG · SUPPOSITORY · RECTAL
PROMETHAZINE HYDROCHLORIDEPrescription
PROMETHAZINE HYDROCHLORIDE 12.5MG · SUPPOSITORY · RECTAL
Approval history
2016-09-02Labeling · Supplement 31 · standardAP
2012-12-18Labeling · Supplement 25AP
2012-12-18Labeling · Supplement 26AP
2010-05-26Labeling · Supplement 24AP
2010-04-26Labeling · Supplement 23AP
2005-10-13Labeling · Supplement 19AP
2004-10-06Labeling · Supplement 8AP
2004-06-18Labeling · Supplement 5AP
2003-03-31Labeling · Supplement 4AP
2003-03-31Manufacturing (CMC) · Supplement 2AP
2002-11-20Labeling · Supplement 1AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.