FDA.reportPublic FDA data

Application 016954

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICRONORNORETHINDRONETABLET;ORAL-280.35MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N016954-001MICRONORNORETHINDRONE0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 1982

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016954-001MICRONOR0.35MGTABLET / ORAL-28RLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 1982a50c72e98297…

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NorethindroneNORETHINDRONEGlenmark Pharmaceuticals Inc., USA0d2f8fea-3675-40d2-afd9-9fcb148dbd4b2026-01-31Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
HEATHERNORETHINDRONEGlenmark Pharmaceuticals Inc., USA35b5ddb5-1729-4588-b2a2-ead56d78b6f92026-01-23Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
NORETHINDRONENORETHINDRONEProficient Rx LPbbd54f1e-2d48-4efa-a57e-7fa7b478c4572026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
JencyclaNORETHINDRONELupin Pharmaceuticals, Inc.e91e7bdd-2984-4332-9b0b-04322792d7f62025-12-08Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
DEBLITANENORETHINDRONENorthstar Rx LLCe75367ff-78af-4bd2-a99d-d291cb1d21eb2025-12-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
SHAROBELNORETHINDRONENorthstar Rx LLCa96f5194-ad2a-4783-a9a9-22a288caff252025-12-05Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
Norethindrone AcetateNORETHINDRONEAvKARE827c7ef1-a8b7-d0c4-b062-c5154b331a352025-09-17Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
MELEYANORETHINDRONEXiromed LLC534c5717-382c-4109-3208-e21b32e4c4c92025-03-06Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
NORETHINDRONENORETHINDRONELupin Pharmaceuticals, Inc.121fbf86-1d76-4579-be2f-be9a957b23ab2025-02-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
NORETHINDRONENORETHINDRONEA-S Medication Solutions70231aa1-9dd2-420f-9cb3-432d3c2477d12025-02-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
OrquideaNORETHINDRONEXiromed, LLC6e9f61a1-93ff-291a-bea8-9307a3b0378e2025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
Norethindrone AcetateNORETHINDRONEAmneal Pharmaceuticals LLC64cb920c-36e8-4d62-9d08-3ddf3989d3132024-10-30Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
AffodelNORETHINDRONENaari Pte. Limited8ec64ec8-fbc9-440d-9838-654a605d57da2024-04-22Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
CAMILANORETHINDRONEDr. Reddy's Labratories Inc.59985565-af09-21ba-0336-3f6db7711bd12024-04-01Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
ERRINNORETHINDRONEDr. Reddy's Labratories Inc.df29577b-c2f0-bea8-b048-7719972707aa2024-03-01Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
ERRINNORETHINDRONEProficient Rx LP904899f2-9c54-44d2-901e-47e8945715002024-01-01Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
EmzahhNORETHINDRONEAurobindo Pharma Limited197d31d3-eec8-49c7-9640-918ff138fea22023-04-10Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
LyleqNORETHINDRONEAfaxys Pharma, LLCc9f00a3e-c827-4066-bf85-079b3a20f25e2023-03-27Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
IncassiaNORETHINDRONEAurobindo Pharma Limited0b87cef0-610c-469d-92ba-4007f4bc38782021-09-14Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
NorethindroneNORETHINDRONEProficient Rx LPfb84b86e-5f1f-4c17-8b69-ff695c5faf552019-11-01Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-194Ortho MicronorNORETHINDRONEJanssen Pharmaceuticals, Inc.NDACurrent
50458-194Ortho MicronorNORETHINDRONEJanssen Pharmaceuticals, Inc.NDACurrent
50458-194Ortho MicronorNORETHINDRONEJanssen Pharmaceuticals, Inc.NDACurrent
50458-194Ortho MicronorNORETHINDRONEJanssen Pharmaceuticals, Inc.NDACurrent
50458-194Ortho MicronorNORETHINDRONEJanssen Pharmaceuticals, Inc.NDACurrent
52544-892JolivetteNORETHINDRONEActavis Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69332SUPPL2021-11-17
69331SUPPL2021-11-17
69324SUPPL2021-11-16
69323SUPPL2021-11-16
33210SUPPL2014-07-02
13061SUPPL2014-06-19
10940SUPPL2008-06-26
13060SUPPL2008-06-24
13059SUPPL2003-10-09