FDA.reportPublic FDA data

Application 201446

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FALLBACK SOLOLEVONORGESTRELTABLET;ORAL1.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57297-852My WaylevonorgestrelLUPIN LIMITEDANDACurrent
57297-852My WaylevonorgestrelLUPIN LIMITEDANDACurrent
57297-852My WaylevonorgestrelLUPIN LIMITEDANDACurrent
57297-853Fallback SololevonorgestrelLUPIN LIMITEDANDACurrent
64122-605AfterPilllevonorgestrelSyzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880ANDACurrent
64122-605AfterPilllevonorgestrelSyzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880ANDACurrent
64122-605AfterPilllevonorgestrelSyzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880ANDACurrent
68071-4294My WaylevonorgestrelNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4294My WaylevonorgestrelNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4294My WaylevonorgestrelNuCare Pharmaceuticals,Inc.ANDACurrent
68180-852My WaylevonorgestrelLupin Pharmaceuticals, Inc.ANDACurrent
68180-852My WaylevonorgestrelLupin Pharmaceuticals, Inc.ANDACurrent
68180-852My WaylevonorgestrelLupin Pharmaceuticals, Inc.ANDACurrent
68180-852My WaylevonorgestrelLupin Pharmaceuticals, Inc.ANDACurrent
68180-852My WaylevonorgestrelLupin Pharmaceuticals, Inc.ANDACurrent
68180-853Fallback SololevonorgestrelLupin Pharmaceuticals, Inc.ANDACurrent
68180-853Fallback SololevonorgestrelLupin Pharmaceuticals, Inc.ANDACurrent
68180-853Fallback SololevonorgestrelLupin Pharmaceuticals, InANDACurrent
68180-853Fallback SololevonorgestrelLupin Pharmaceuticals, Inc.ANDACurrent
71205-361My WaylevonorgestrelProficient Rx LPANDACurrent
76519-1164LEVONORGESTRELLEVONORGESTRELH.J. Harkins Company, Inc.ANDACurrent