Home Applications 201661 Application 201661
Type ANDA
Sponsor LUPIN LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NIKKI DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL 3MG;0.02MG 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 A201661-001 NIKKI DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2014-05-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201661-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201661-001 NIKKI 3MG;0.02MG TABLET / ORAL AB 2014-05-27 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 Nikki DROSPIRENONE AND ETHINYL ESTRADIOL Lupin Pharmaceuticals, Inc. 9aff6034-044c-466d-bf52-18a998d47f66 2025-12-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201661 application number: ANDA201661 ndc (product): 68180-886
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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 57297-886 Nikki drospirenone and ethinyl estradiol LUPIN LIMITED ANDA Current 68180-886 Nikki drospirenone and ethinyl estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-886 Nikki drospirenone and ethinyl estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-886 Nikki drospirenone and ethinyl estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-886 Nikki drospirenone and ethinyl estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-886 Nikki drospirenone and ethinyl estradiol Lupin Pharmaceuticals, In ANDA Current 68180-886 Nikki drospirenone and ethinyl estradiol Lupin Pharmaceuticals, Inc. ANDA Current