Application 204305

Type: ANDA
Sponsor: TEVA PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETHINYL ESTRADIOL; ETONOGESTREL	ETHINYL ESTRADIOL; ETONOGESTREL	RING;VAGINAL	0.015MG/24HR;0.12MG/24HR	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB		2021-01-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204305-001	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204305-001	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2021-01-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204305-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204305-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204305-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204305-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204305-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204305-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204305-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204305-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204305-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204305-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204305-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204305-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204305-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204305-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204305-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204305-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204305-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204305-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204305-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204305-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204305-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204305-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204305-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204305-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204305-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204305-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204305-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204305-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204305-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204305-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204305-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204305-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204305-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204305-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204305-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204305-001	AB	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etonogestrel and Ethinyl Estradiol	ETONOGESTREL AND ETHINYL ESTRADIOL	Teva Pharmaceuticals USA, Inc.	a8cc104a-d522-49ad-af54-2f312b829b61	2022-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204305 application number: ANDA204305 ndc (product): 0093-7679

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7679	Etonogestrel and Ethinyl Estradiol	Etonogestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7679	Etonogestrel and Ethinyl Estradiol	Etonogestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current