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FDA ANDA · ANDA204658
HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Sponsor: PADAGIS US
APPLICATION
ANDA204658
TYPE
ANDA
ORIGINAL APPROVAL
2014-04-29
LATEST ACTION
2025-03-31
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
2025-03-31Labeling · Supplement 4 · standardAP
2023-12-15Labeling · Supplement 3 · standardAP
2023-10-18Labeling · Supplement 1 · standardAP
2023-10-18Labeling · Supplement 2 · standardAP
2014-04-29UNKNOWN · OriginalAP
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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