FDA.report

Application 021998

Type
NDA
Sponsor
FDN CONSUMER

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001PLAN B ONE-STEPLEVONORGESTRELTABLET;ORAL1.5MGYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-973Plan B One-SteplevonorgestrelRebel Distributors CorpNDACurrent
50090-1141Plan B One-StepLevonorgestrelA-S Medication SolutionsNDACurrent
50090-1141Plan B One-StepLevonorgestrelA-S Medication SolutionsNDACurrent
50090-3830Plan B One-SteplevonorgestrelA-S Medication SolutionsNDACurrent
50090-3830Plan B One-SteplevonorgestrelA-S Medication SolutionsNDACurrent
50090-5978Plan B One-SteplevonorgestrelA-S Medication SolutionsNDACurrent
51285-100Take ActionLevonorgestrelTeva Women's Health, Inc.NDA AUTHORIZED GENERICCurrent
51285-103AfteralevonorgestrelTeva Women's Health, Inc.NDA AUTHORIZED GENERICCurrent
51285-103AfteralevonorgestrelTeva Women's Health, Inc.NDA AUTHORIZED GENERICCurrent
51285-146Plan B One-StepLevonorgestrelTeva Women's Health, Inc.NDACurrent
51285-162Plan B One-StepLevonorgestrelTeva Women's Health, Inc.NDACurrent
68071-4126LevonorgestrelLevonorgestrelNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
69536-103AfteraLEVONORGESTRELFoundation Consumer Healthcare LLCNDA AUTHORIZED GENERICCurrent
69536-103AfteraLEVONORGESTRELFoundation Consumer Healthcare LLCNDA AUTHORIZED GENERICCurrent
69536-103AfteraLEVONORGESTRELFoundation Consumer Healthcare LLCNDA AUTHORIZED GENERICCurrent
69536-133Next Choice One DoselevonorgestrelFoundation Consumer Healthcare LLCNDA AUTHORIZED GENERICCurrent
69536-146Plan B One-SteplevonorgestrelFoundation Consumer Healthcare LLCNDACurrent
69536-146Plan B One-SteplevonorgestrelFoundation Consumer Healthcare LLCNDACurrent
69536-146Plan B One-SteplevonorgestrelFoundation Consumer Healthcare LLCNDACurrent
69536-162Plan B One-SteplevonorgestrelFoundation Consumer Healthcare LLCNDACurrent
69536-162Plan B One-SteplevonorgestrelFoundation Consumer Healthcare LLCNDACurrent
69536-162Plan B One-SteplevonorgestrelFoundation Consumer Healthcare LLCNDACurrent
69536-200Take ActionlevonorgestrelFoundation Consumer Healthcare LLCNDA AUTHORIZED GENERICCurrent
69536-200Take ActionlevonorgestrelFoundation Consumer Healthcare LLCNDA AUTHORIZED GENERICCurrent
69536-200Take ActionlevonorgestrelFoundation Consumer Healthcare LLCNDA AUTHORIZED GENERICCurrent
76413-323Plan B One-StepLevonorgestrelCentral Texas Community Health CentersNDACurrent

Documents

DocumentSubmission typeDate
73035SUPPL2022-12-23
73034SUPPL2022-12-23
73032SUPPL2022-12-23
57408SUPPL2019-02-04
57138SUPPL2019-01-08
49414SUPPL2017-08-15
49413SUPPL2017-08-15
42378SUPPL2015-11-17
38048SUPPL2013-09-24
6645SUPPL2013-06-24
16725SUPPL2013-06-21
6644SUPPL2013-05-02
42377ORIG2009-11-24
24230ORIG2009-11-24
38047ORIG2009-07-13
29024ORIG2009-07-13
53321ORIG1900-01-01
53320ORIG1900-01-01
53319ORIG1900-01-01
53318ORIG1900-01-01
53317ORIG1900-01-01