Application 022252

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NATAZIADIENOGEST; ESTRADIOL VALERATETABLET;ORALN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/AYesYes

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
N022252-001NATAZIADIENOGEST; ESTRADIOL VALERATEN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022252-00180715772026-05-13U-1Drug product2011-12-30
N022252-00181536162028-01-30U-12402012-05-09

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 UTC2026-02N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-0687673890dc5c…
2021-03-12 10:30 UTC2021-03N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-063f01610625f2…
2019-09-15 20:21 UTC2019-09N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06b00525d2431f…
2019-07-19 19:46 UTC2019-07N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-063f0d92c62455…
2023-05-13 08:27 UTC2023-05N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06053a50430f4f…
2023-01-26 05:58 UTC2023-01N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022252-001NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET / ORALRLD, RS2010-05-06cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022252-00180715772026-05-13U-1Drug product2011-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022252-00181536162028-01-30U-12402012-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022252-00180715772026-05-13U-1Drug product2011-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022252-00181536162028-01-30U-12402012-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N022252-00180715772026-05-13U-1Drug product2011-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022252-00181536162028-01-30U-12402012-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022252-00180715772026-05-13U-1Drug product2011-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022252-00181536162028-01-30U-12402012-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022252-00180715772026-05-13U-1Drug product2011-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022252-00181536162028-01-30U-12402012-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022252-00180715772026-05-13U-1Drug product2011-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022252-00181536162028-01-30U-12402012-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022252-00180715772026-05-13U-1Drug product2011-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022252-00181536162028-01-30U-12402012-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022252-00180715772026-05-13U-1Drug product2011-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022252-00181536162028-01-30U-12402012-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022252-00180715772026-05-13U-1Drug product2011-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022252-00181536162028-01-30U-12402012-05-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022252-00180715772026-05-13U-1Drug product2011-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N022252-00181536162028-01-30U-12402012-05-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022252-00180715772026-05-13U-1Drug product2011-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022252-00181536162028-01-30U-12402012-05-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022252-00180715772026-05-13U-1Drug product2011-12-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022252-00181536162028-01-30U-12402012-05-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022252-00180715772026-05-13U-1Drug product2011-12-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022252-00181536162028-01-30U-12402012-05-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022252-00180715772026-05-13U-1Drug product2011-12-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022252-00181536162028-01-30U-12402012-05-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022252-00180715772026-05-13U-1Drug product2011-12-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022252-00181536162028-01-30U-12402012-05-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022252-00180715772026-05-13U-1Drug product2011-12-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022252-00181536162028-01-30U-12402012-05-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022252-00180715772026-05-13U-1Drug product2011-12-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022252-00181536162028-01-30U-12402012-05-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022252-00180715772026-05-13U-1Drug product2011-12-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022252-00181536162028-01-30U-12402012-05-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022252-00180715772026-05-13U-1Drug product2011-12-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022252-00181536162028-01-30U-12402012-05-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022252-00180715772026-05-13U-1Drug product2011-12-30782e0a99824c…
2021-12-28 21:50 UTC2021-12N022252-00181536162028-01-30U-12402012-05-09782e0a99824c…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NataziaESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGESTBayer HealthCare Pharmaceuticals Inc.02c91fba-9c47-43ef-ac78-e823697988342024-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022252
application number: NDA022252
ndc (product): 50419-409
Estradiol Valerate and Estradiol Valerate/DienogestESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGESTSandoz Inc0c3ac139-af85-4c70-ad3d-981e57d86f022020-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022252
application number: NDA022252
ndc (product): 0781-4110

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-4110Estradiol Valerate and Estradiol Valerate/Dienogestestradiol valerate and estradiol valerate/dienogestSandoz IncNDA AUTHORIZED GENERICCurrent
0781-4110Estradiol Valerate and Estradiol Valerate/Dienogestestradiol valerate and estradiol valerate/dienogestSandoz IncNDA AUTHORIZED GENERICCurrent
0781-4110Estradiol Valerate and Estradiol Valerate/Dienogestestradiol valerate and estradiol valerate/dienogestSandoz IncNDA AUTHORIZED GENERICCurrent
50419-409Nataziaestradiol valerate and estradiol valerate/dienogestBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-409Nataziaestradiol valerate and estradiol valerate/dienogestBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-409Nataziaestradiol valerate and estradiol valerate/dienogestBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-409Nataziaestradiol valerate and estradiol valerate/dienogestBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-409Nataziaestradiol valerate and estradiol valerate/dienogestBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-409Nataziaestradiol valerate and estradiol valerate/dienogestBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78917SUPPL 2024-06-27
78906SUPPL 2024-06-27
70940SUPPL2022-05-03
70912SUPPL2022-05-03
38431SUPPL2015-08-25
7099SUPPL2015-08-24
29456SUPPL2013-08-23
17135SUPPL2013-08-22
38430ORIG2012-03-16
7098ORIG2012-03-16
29455SUPPL2012-02-15
17134SUPPL2012-02-14
24265ORIG2010-06-06
21970ORIG2010-06-06
17133ORIG2010-05-17
7097ORIG2010-05-12
63519ORIG1900-01-01
53269ORIG1900-01-01
53268ORIG1900-01-01