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 1.

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N016954-001MICRONORNORETHINDRONE0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 1982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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016954-001MICRONOR0.35MGTABLET / ORAL-28RLD, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016954-001MICRONOR0.35MGTABLET / ORAL-28RLD, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016954-001MICRONOR0.35MGTABLET / ORAL-28RLD, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016954-001MICRONOR0.35MGTABLET / ORAL-28RLD, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016954-001MICRONOR0.35MGTABLET / ORAL-28RLD, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N016954-001MICRONOR0.35MGTABLET / ORAL-28RLD, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N016954-001MICRONOR0.35MGTABLET / ORAL-28RLD, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N016954-001MICRONOR0.35MGTABLET / ORAL-28RLD, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N016954-001MICRONOR0.35MGTABLET / ORAL-28RLD, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N016954-001MICRONOR0.35MGTABLET / ORAL-28RLD, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N016954-001MICRONOR0.35MGTABLET / ORAL-28RLD, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N016954-001MICRONOR0.35MGTABLET / ORAL-28RLD, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N016954-001MICRONOR0.35MGTABLET / ORAL-28RLD, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N016954-001MICRONOR0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD, Approved before 19823a93d1ddd44b…
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…

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 · 24 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
Nora BENORETHINDRONETeva Pharmaceuticals, Inc.426ac898-7745-4645-bf9b-bae319e260e82024-04-02Warnings, 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
ERRINNORETHINDRONEMayne Pharma Inc.32e6366a-8bb4-4b67-b4a3-e372c7696fa72022-03-29Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE

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