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FDA ANDA · ANDA079043
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI
Sponsor: DR REDDYS LABS LTD
APPLICATION
ANDA079043
TYPE
ANDA
ORIGINAL APPROVAL
2010-03-17
LATEST ACTION
2022-05-17
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter
Products
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEOver-the-counter
FEXOFENADINE HYDROCHLORIDE 180MG, PSEUDOEPHEDRINE HYDROCHLORIDE 240MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-05-17Manufacturing (CMC) · Supplement 6 · unknownAP
2016-01-26Labeling · Supplement 5 · standardAP
2010-05-28Labeling · Supplement 1AP
2010-03-17OriginalAP
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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