Application 213034

Type: ANDA
Sponsor: HETERO LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	TABLET;ORAL-28	3MG;0.03MG	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB		2020-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213034-001	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
2026-09-14 22:38:34	2026-08	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213034-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2020-01-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213034-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213034-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213034-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213034-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213034-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213034-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213034-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213034-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213034-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213034-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213034-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213034-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213034-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213034-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213034-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213034-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213034-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213034-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213034-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213034-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213034-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213034-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213034-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213034-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213034-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213034-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213034-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213034-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213034-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213034-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213034-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213034-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213034-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213034-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213034-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213034-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213034-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213034-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213034-001	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
Drospirenone and Ethinyl Estradiol	DROSPIRENONE AND ETHINYL ESTRADIOL	Camber Pharmaceuticals, Inc.	a1f6ea0e-7c14-47c4-83a2-3797bd012eb4	2023-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213034 application number: ANDA213034 ndc (product): 31722-945

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-945	Drospirenone and Ethinyl Estradiol	Drospirenone and Ethinyl Estradiol	Camber Pharmaceuticals, Inc.	ANDA	Current