← FDA DRUG APPROVALS

FDA ANDA · ANDA085368

ANALPRAM HC

hydrocortisone acetate and pramoxine hydrochloride

Sponsor: LEGACY

APPLICATION
ANDA085368
TYPE
ANDA
ORIGINAL APPROVAL
1977-01-07
LATEST ACTION
2001-12-06
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

PRAMOSONEPrescription
HYDROCORTISONE ACETATE 1%, PRAMOXINE HYDROCHLORIDE 1% · CREAM · TOPICAL

Approval history

2001-12-06Manufacturing (CMC) · Supplement 23AP
2001-09-21Manufacturing (CMC) · Supplement 22AP
2001-09-21Manufacturing (CMC) · Supplement 21AP
2001-02-05Manufacturing (CMC) · Supplement 20AP
2000-09-21Manufacturing (CMC) · Supplement 19AP
2000-08-11Manufacturing (CMC) · Supplement 18AP
1999-03-01Manufacturing (CMC) · Supplement 17AP
1992-08-20Manufacturing (CMC) · Supplement 16AP
1992-06-03Manufacturing (CMC) · Supplement 14AP
1992-06-03Labeling · Supplement 15AP
1992-06-03Manufacturing (CMC) · Supplement 13AP
1992-06-03Labeling · Supplement 11AP
1992-04-27Manufacturing (CMC) · Supplement 12AP
1992-04-27Manufacturing (CMC) · Supplement 9AP
1992-04-27Labeling · Supplement 8AP
1988-11-07Manufacturing (CMC) · Supplement 10AP
1984-12-21Manufacturing (CMC) · Supplement 7AP
1984-12-21Manufacturing (CMC) · Supplement 6AP
1977-01-07OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →