Home Applications 209407 Application 209407
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZUMANDIMINE DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL-28 3MG;0.03MG 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 A209407-001 ZUMANDIMINE DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209407-001 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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 Zumandimine DROSPIRENONE AND ETHINYL ESTRADIOL Aurobindo Pharma Limited 192ad3b0-9ef2-409d-a851-77712202c45a 2023-10-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209407 application number: ANDA209407 ndc (product): 59651-030
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59651-030 Zumandimine Drospirenone and Ethinyl Estradiol Aurobindo Pharma Limited ANDA Current 59651-030 Zumandimine Drospirenone and Ethinyl Estradiol Aurobindo Pharma Limited ANDA Current 59651-030 Zumandimine Drospirenone and Ethinyl Estradiol Aurobindo Pharma Limited ANDA Current 59651-030 Zumandimine Drospirenone and Ethinyl Estradiol Aurobindo Pharma Limited ANDA Current 59651-030 Zumandimine Drospirenone and Ethinyl Estradiol Aurobindo Pharma Limited ANDA Current 59651-030 Zumandimine Drospirenone and Ethinyl Estradiol Aurobindo Pharma Limited ANDA Current 59651-030 Zumandimine Drospirenone and Ethinyl Estradiol Aurobindo Pharma Limited ANDA Current