Application 200407

Type: ANDA
Sponsor: MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	TABLET;ORAL	0.02MG,0.1MG;0.01MG,N/A	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL			2011-10-25

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2011-10-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2011-10-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2011-10-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2011-10-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2011-10-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2011-10-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2011-10-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2011-10-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2011-10-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2011-10-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2011-10-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2011-10-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2011-10-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL		2011-10-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200407-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2011-10-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200407-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200407-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200407-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200407-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200407-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200407-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200407-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200407-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200407-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200407-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200407-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200407-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200407-001	AB	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200407-001	AB	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol	LEVONORGESTREL AND ETHINYL ESTRADIOL	Lupin Pharmaceuticals, Inc.	7d82aa5d-aee9-4c72-9b9b-af7adad21f4c	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	5c1d0a3a-1b24-44a0-9c53-224365b65945	2023-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	ada28708-ab65-4c07-a695-9141c5ce26bc	2023-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9824	ORIG	2011-10-31