Application 204061

Type
NDA
Sponsor
TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUARTETTEETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/AYesYes

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
N204061-001QUARTETTEETHINYL ESTRADIOL; LEVONORGESTREL0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N204061-001AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204061-00184153322029-03-11Drug product2013-04-16

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-2884e616aacf4f…
2026-08-18 06:07:402026-07N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N204061-001QUARTETTE0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET / ORALABRLD, RS2013-03-28f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-09-29 23:25 UTC2022-09N204061-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N204061-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N204061-001AB1a50c72e98297…

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
2026-09-14 22:38:342026-08N204061-00184153322029-03-11Drug product2013-04-1684e616aacf4f…
2026-08-18 06:07:402026-07N204061-00184153322029-03-11Drug product2013-04-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204061-00184153322029-03-11Drug product2013-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204061-00184502992025-10-07U-12013-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204061-00184153322029-03-11Drug product2013-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N204061-00184502992025-10-07U-12013-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204061-00184153322029-03-11Drug product2013-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204061-00184502992025-10-07U-12013-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204061-00184153322029-03-11Drug product2013-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204061-00184502992025-10-07U-12013-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204061-00184153322029-03-11Drug product2013-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204061-00184502992025-10-07U-12013-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204061-00184153322029-03-11Drug product2013-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204061-00184502992025-10-07U-12013-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204061-00184153322029-03-11Drug product2013-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204061-00184502992025-10-07U-12013-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204061-00184153322029-03-11Drug product2013-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204061-00184502992025-10-07U-12013-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204061-00184153322029-03-11Drug product2013-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204061-00184502992025-10-07U-12013-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N204061-00184153322029-03-11Drug product2013-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204061-00184502992025-10-07U-12013-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204061-00184153322029-03-11Drug product2013-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204061-00184502992025-10-07U-12013-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204061-00184153322029-03-11Drug product2013-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204061-00184502992025-10-07U-12013-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204061-00184153322029-03-11Drug product2013-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204061-00184502992025-10-07U-12013-06-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05N204061-00184153322029-03-11Drug product2013-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204061-00184502992025-10-07U-12013-06-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204061-00184153322029-03-11Drug product2013-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204061-00184502992025-10-07U-12013-06-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N204061-00184153322029-03-11Drug product2013-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204061-00184502992025-10-07U-12013-06-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N204061-00184153322029-03-11Drug product2013-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204061-00184502992025-10-07U-12013-06-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204061-00184153322029-03-11Drug product2013-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204061-00184502992025-10-07U-12013-06-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N204061-00184153322029-03-11Drug product2013-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N204061-00184502992025-10-07U-12013-06-11782e0a99824c…

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-6031RivelsaLevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-6031RivelsaLevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-6031RivelsaLevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-6031RivelsaLevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-6031RivelsaLevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-6031RivelsaLevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51862-489Levonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolLevonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolMayne Pharma Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71745SUPPL2022-08-08
71744SUPPL2022-08-08
71727SUPPL2022-08-05
71726SUPPL2022-08-05
70949SUPPL2022-05-03
70898SUPPL2022-05-02
49382SUPPL2017-08-15
49333SUPPL2017-08-11
44893ORIG2013-04-25
22940ORIG2013-04-25
19519ORIG2013-04-01
32497ORIG2013-03-29
51305ORIG1900-01-01
51304ORIG1900-01-01
51303ORIG1900-01-01
51302ORIG1900-01-01