Home Applications 091105 Application 091105
Type ANDA
Sponsor NOVAST LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ELINEST ETHINYL ESTRADIOL; NORGESTREL TABLET;ORAL-28 0.03MG;0.3MG 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 A091105-001 ELINEST ETHINYL ESTRADIOL; NORGESTREL 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091105-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 Elinest NORGESTREL AND ETHINYL ESTRADIOL Northstar Rx LLC aa7f4a83-71cf-4306-b0a1-01784f67bae2 2025-12-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091105 application number: ANDA091105 ndc (product): 16714-365
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 16714-365 Elinest Norgestrel and Ethinyl Estradiol Northstar Rx LLC ANDA Current