Public View of Products Suspended, Withdrawn or Revoked

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Products Suspended, Withdrawn or Revoked

#Local Technical RepresentativeApplication NumberProduct Trade NameHuman VetLocal ForeignInn Of ApiApi Strength Per DosageProduct Registration NoDosage Form NameRoutes NameShelf Life NameProduct Visual DescAtc Code NamePharmacotherapeutic GroupMah Company NameMah Company AddressMah Company EmailSite NameSite AddressStatus NameStatus DescriptionGmp Status
1SURGILINKS LTD120FemigirlForeignCyproterone Acetate BP Ethinylestradiol BPCyproterone Acetate BP 2mg Ethinylestradiol BP…19931TabletORAL24 monthsLight - orange and round bioconvex tablets.G03HBCombinations of Antiandrogens and estrogensMylan Laboratories Limited- Women’s Health CarePlot No.564/A/22 Road No.92, Jubilee Hills…sasikumar@mylan.inMylan Laboratories Limited –Women’s Health CarePlot No.: 1606-1609, G.I.D.C., Sarigam, Tal…SuspendedRegulatory decisionGMP Site is Invalid
2NVS KENYA LTD263Baneocin PowderForeignBacitracin+NeomycinBACITRACIN ZINC+NEOMYCIN SULPHATE PWD 250 IU +…1315Powder And Solvent For Cutaneous SolutionTOPICAL36 monthsBaneocin powder is a fine white to yellowish…D06AXOther antibiotics for topical useSandoz GmbH KundlBiochemiestrasse 10A-6250 Kundl / TirolAustria.winnie.munene@sandoz.comMONTAVIT GES. MBHSALZBERGSTR. 96, A-6067 ABSAM, AUSTRIAWithdrawnInitiated by the clientGMP Site is Invalid
3SURGILINKS LTD290Hyan FC TabletsForeignLevonorgestrel TabletsLevonorgestrel BP 0.03 mg16732TabletORAL60 monthsWhite to off-white circular biconvex film coated…G03AAHormonal contraceptives: Fixed Combinations of…Mylan Laboratories Limited - Womens Health CarePlot not 564/A/22, Road NO.92 Jubilee hills,…mylan.india@mylan.inMylan Laboratories Limited –Women’s Health CarePlot No.: 1606-1609, G.I.D.C., Sarigam, Tal…SuspendedRegulatory decisionGMP Site is Invalid
4SURGILINKS LTD291Oralcon Film Coated TabletsForeignLevonorgestrel and Ethinylestradiol TabletsLevonorgestrel BP 015mg Ethinylestradiol BP 003mg16176TabletORAL60 monthsWhite circular biconvex film coated tablets.G03AAHormonal contraceptives: Fixed Combinations of…Mylan Laboratories Limited- Womens Health CarePlot No.564/A/22 Road No.92, Jubilee Hills…mylan.india@mylan.inMylan Laboratories Limited –Women’s Health CarePlot No.: 1606-1609, G.I.D.C., Sarigam, Tal…SuspendedRegulatory decisionGMP Site is Invalid
5SURGILINKS LTD293P2ForeignLevonorgestrel TabletsLevonorgestrel BP 0.75 mg16177TabletORAL60 monthsWhite circular biconvex uncoated tablets.G03ACHormonal contraceptives: Progestogens for…Mylan Laboratories Limited- Women’s Health CarePlot No.564/A/22 Road No.92, Jubilee Hills…sasikumar@mylan.inMylan Laboratories Limited –Women’s Health CarePlot No.: 1606-1609, G.I.D.C., Sarigam, Tal…SuspendedRegulatory decisionGMP Site is Invalid
6SURGILINKS LTD294P1ForeignLevonorgestrel BPLevonorgestrel BP 1.5 mg21198TabletORAL24 monthsWhite circular biconvex uncoated tablets with F55…G03AAHormonal contraceptives: Fixed Combinations of…Mylan Laboratories Limited- Women’s Health CarePlot No.564/A/22 Road No.92, Jubilee Hills…sasikumar@mylan.inMylan Laboratories Limited –Women’s Health CarePlot No.: 1606-1609, G.I.D.C., Sarigam, Tal…SuspendedRegulatory decisionGMP Site is Invalid
7SURGILINKS LTD295Julee TabletsForeignDesogestrel BP Ethinyl Estradiol USPDesogestrel BP 015mgEthinyl Estradiol USP 003mg21943TabletORAL24 monthsRound white to off white uncoate biconvex tablets…G03AAHormonal contraceptives: Fixed Combinations of…Mylan Laboratories Limited- Women’s Health CarePlot No.564/A/22 Road No.92, Jubilee Hills…sasikumar@mylan.inMylan Laboratories Limited –Women’s Health CarePlot No.: 1606-1609, G.I.D.C., Sarigam, Tal…SuspendedRegulatory decisionGMP Site is Invalid
8SURGILINKS LTD298ZinniaForeignLevonorgestrel and Ethinylestradiol TabletsLevonorgestrel 150mcg and Ethinylestradiol 30mcg…H2013/CTD/595/273TabletORAL48 monthsWhitecircularbiconvex sugar coated tablets.G03AAHormonal contraceptives: Fixed Combinations of…Mylan Laboratories Limited- Women’s Health CarePlot No.564/A/22 Road No.92, Jubilee Hills…sasikumar@mylan.inMylan Laboratories Limited –Women’s Health CarePlot No.: 1606-1609, G.I.D.C., Sarigam, Tal…SuspendedRegulatory decisionGMP Site is Invalid
9SURGILINKS LTD300Zinnia PForeignLevonorgestrel and Ethinylestradiol TabletsLevonorgestrel Ph. Eur. 150 mcg and…H2013/CTD/667/073TabletORAL48 monthsWhite circular biconvex sugar coated tablets.…G03AAHormonal contraceptives: Fixed Combinations of…Mylan Laboratories Limited- Women’s Health CarePlot No.564/A/22 Road No.92, Jubilee Hills…sasikumar@mylan.inMylan Laboratories Limited –Women’s Health CarePlot No.: 1606-1609, G.I.D.C., Sarigam, Tal…SuspendedRegulatory decisionGMP Site is Invalid
10PHILLIPS THERAPEUTICS LIMITED590GLURENORForeignGliquidone30 mg9711TabletORAL48 monthsFlat round white bevel-edged tablets scored on…A10BBBlood glucose lowering drugs excluding insulins:…Laboratori Guidotti S.p.A.Via Livornese 897 56122- La Vettola Pisa Italyprijli@menarini.itA. Menarini Manufacturing Logistics and Services…Via Campo di Pile, 67100 L Aquila ItalyWithdrawnInitiated by the clientGMP Site Approved
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