FDA.reportPublic FDA data

Application 021998

Type
NDA
Sponsor
FDN CONSUMER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PLAN B ONE-STEPLEVONORGESTRELTABLET;ORAL1.5MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021998-001PLAN B ONE-STEPLEVONORGESTREL1.5MGTABLET / ORALRLD, RS2009-07-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N021998-001PLAN B ONE-STEP1.5MGTABLET / ORALRLD, RS2009-07-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021998-001PLAN B ONE-STEP1.5MGTABLET / ORALRLD, RS2009-07-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021998-001PLAN B ONE-STEP1.5MGTABLET / ORALRLD, RS2009-07-10a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Plan B One-StepLEVONORGESTRELA-S Medication Solutionsfcc7ba8e-ad54-4efe-87e4-5eb0fbf4f0642023-10-24WarningsExact identifier
application applno (NDA): 021998
application number: NDA021998
ndc (product): 50090-5978
Next Choice One DoseLEVONORGESTRELFoundation Consumer Healthcare LLC504735bd-6af9-4588-bf85-d09dbf2a7e412023-02-02WarningsExact identifier
application applno (NDA): 021998
application number: NDA021998
ndc (product): 69536-133
Take ActionLEVONORGESTRELFoundation Consumer Healthcare LLC78eee7c9-5ca5-45af-898f-92a2f3b2598e2023-01-31WarningsExact identifier
application applno (NDA): 021998
application number: NDA021998
ndc (product): 69536-200
AfteraLEVONORGESTRELFoundation Consumer Healthcare LLC53ad8dff-9134-475c-90b3-8087753e17c42023-01-31WarningsExact identifier
application applno (NDA): 021998
application number: NDA021998
ndc (product): 69536-103
Plan B One-StepLEVONORGESTRELFoundation Consumer Healthcare LLC6ce6b40e-14ac-47bd-a648-ddf9e452e5592023-01-31WarningsExact identifier
application applno (NDA): 021998
application number: NDA021998
ndc (product): 69536-146
ndc (product): 69536-162

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
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#

Document, Submission type, Date table
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