Application 209632

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LO-ZUMANDIMINE	DROSPIRENONE; ETHINYL ESTRADIOL	TABLET;ORAL	3MG;0.02MG	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
A209632-001	LO-ZUMANDIMINE	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET / ORAL	AB		2018-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209632-001	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.

Product history page 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209632-001	LO-ZUMANDIMINE	3MG;0.02MG	TABLET / ORAL	AB	2018-02-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209632-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209632-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209632-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209632-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209632-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209632-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209632-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209632-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209632-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209632-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209632-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209632-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209632-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209632-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209632-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209632-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209632-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209632-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209632-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209632-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209632-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209632-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209632-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209632-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209632-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209632-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209632-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209632-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209632-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209632-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209632-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209632-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209632-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209632-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209632-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209632-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209632-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209632-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209632-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209632-001	AB	1	`e64feba35796…`

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
Drospirenone and Ethinyl Estradiol	DROSPIRENONE AND ETHINYL ESTRADIOL	NorthStar Rx LLC	c88c3eb8-3bf5-4004-a7ab-7218cd2f9182	2025-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209632 application number: ANDA209632
Jasmiel	DROSPIRENONE AND ETHINYL ESTRADIOL	Afaxys Pharma, LLC	1a3211f8-41f5-4905-a466-0d79add5fdad	2024-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209632 application number: ANDA209632 ndc (product): 50102-240
Lo-Zumandimine	DROSPIRENONE AND ETHINYL ESTRADIOL	Aurobindo Pharma Limited	a8c718cc-e235-4710-a9e6-6c58433f3028	2023-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209632 application number: ANDA209632 ndc (product): 59651-029

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50102-240	Jasmiel	Drospirenone and Ethinyl Estradiol	Afaxys Pharma, LLC	ANDA	Current
50102-240	Jasmiel	Drospirenone and Ethinyl Estradiol	Afaxys Pharma, LLC	ANDA	Current
50102-240	Jasmiel	Drospirenone and Ethinyl Estradiol	Afaxys Pharma, LLC	ANDA	Current
50102-240	Jasmiel	Drospirenone and Ethinyl Estradiol	Afaxys Pharma, LLC	ANDA	Current
50102-240	Jasmiel	Drospirenone and Ethinyl Estradiol	Afaxys Pharma, LLC	ANDA	Current
50102-240	Jasmiel	Drospirenone and Ethinyl Estradiol	Afaxys Pharma, LLC	ANDA	Current
50102-240	Jasmiel	Drospirenone and Ethinyl Estradiol	Afaxys Pharma, LLC	ANDA	Current
53002-1783	Jasmiel	Drospirenone and Ethinyl Estradiol	RPK Pharmaceuticals, Inc.	ANDA	Current
59651-029	Lo-Zumandimine	Drospirenone and Ethinyl Estradiol	Aurobindo Pharma Limited	ANDA	Current
59651-029	Lo-Zumandimine	Drospirenone and Ethinyl Estradiol	Aurobindo Pharma Limited	ANDA	Current
59651-029	Lo-Zumandimine	Drospirenone and Ethinyl Estradiol	Aurobindo Pharma Limited	ANDA	Current
59651-029	Lo-Zumandimine	Drospirenone and Ethinyl Estradiol	Aurobindo Pharma Limited	ANDA	Current
59651-029	Lo-Zumandimine	Drospirenone and Ethinyl Estradiol	Aurobindo Pharma Limited	ANDA	Current
59651-029	Lo-Zumandimine	Drospirenone and Ethinyl Estradiol	Aurobindo Pharma Limited	ANDA	Current