Home Applications 204061 Application 204061
Type NDA
Sponsor TEVA BRANDED PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 QUARTETTE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204061-001 QUARTETTE ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A TABLET / ORAL AB RLD, RS 2013-03-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N204061-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204061-001 8415332 2029-03-11 Drug product 2013-04-16
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 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N204061-001 QUARTETTE 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A TABLET / ORAL AB RLD, RS 2013-03-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N204061-001 QUARTETTE 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A TABLET / ORAL AB RLD, RS 2013-03-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N204061-001 QUARTETTE 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A TABLET / ORAL AB RLD, RS 2013-03-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N204061-001 QUARTETTE 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A TABLET / ORAL AB RLD, RS 2013-03-28 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 83 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204061-001 8450299 2025-10-07 U-1 2013-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204061-001 8450299 2025-10-07 U-1 2013-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204061-001 8450299 2025-10-07 U-1 2013-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204061-001 8450299 2025-10-07 U-1 2013-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204061-001 8450299 2025-10-07 U-1 2013-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204061-001 8450299 2025-10-07 U-1 2013-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204061-001 8450299 2025-10-07 U-1 2013-06-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204061-001 8450299 2025-10-07 U-1 2013-06-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204061-001 8450299 2025-10-07 U-1 2013-06-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204061-001 8450299 2025-10-07 U-1 2013-06-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204061-001 8450299 2025-10-07 U-1 2013-06-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204061-001 8450299 2025-10-07 U-1 2013-06-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204061-001 8450299 2025-10-07 U-1 2013-06-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204061-001 8450299 2025-10-07 U-1 2013-06-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204061-001 8450299 2025-10-07 U-1 2013-06-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204061-001 8450299 2025-10-07 U-1 2013-06-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204061-001 8450299 2025-10-07 U-1 2013-06-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204061-001 8450299 2025-10-07 U-1 2013-06-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N204061-001 8415332 2029-03-11 Drug product 2013-04-16 bb7c543d1eb4…
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 NDC Name Nonproprietary name Labeler Marketing category Status 0093-6031 Rivelsa Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Teva Pharmaceuticals USA, Inc. NDA AUTHORIZED GENERIC Current 0093-6031 Rivelsa Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Teva Pharmaceuticals USA, Inc. NDA AUTHORIZED GENERIC Current 0093-6031 Rivelsa Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Teva Pharmaceuticals USA, Inc. NDA AUTHORIZED GENERIC Current 0093-6031 Rivelsa Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Teva Pharmaceuticals USA, Inc. NDA AUTHORIZED GENERIC Current 0093-6031 Rivelsa Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Teva Pharmaceuticals USA, Inc. NDA AUTHORIZED GENERIC Current 0093-6031 Rivelsa Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Teva Pharmaceuticals USA, Inc. NDA AUTHORIZED GENERIC Current 51285-431 QUARTETTE Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Teva Women's Health, Inc. NDA Current 51285-431 QUARTETTE Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Teva Women's Health, Inc. NDA Current 51285-431 QUARTETTE Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Teva Women's Health, Inc. NDA Current 51285-431 QUARTETTE Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Teva Women's Health, Inc. NDA Current 51285-431 QUARTETTE Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Teva Women's Health, Inc. NDA Current 51285-431 QUARTETTE Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Teva Women's Health, Inc. NDA Current 51285-431 QUARTETTE Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Teva Women's Health, Inc. NDA Current 51285-431 QUARTETTE Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Teva Women's Health, Inc. NDA Current 51285-431 QUARTETTE Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Teva Women's Health, Inc. NDA Current 51862-489 Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current