← FDA DRUG APPROVALS
FDA ANDA · ANDA205658
HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Sponsor: MAYNE PHARMA INC
APPLICATION
ANDA205658
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-17
LATEST ACTION
2015-11-17
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDEDiscontinued
HYDROCODONE BITARTRATE 5MG/5ML, PSEUDOEPHEDRINE HYDROCHLORIDE 60MG/5ML · SOLUTION · ORAL
Approval history
2015-11-17UNKNOWN · 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.
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.