Home Applications 073594 Application 073594
Type ANDA
Sponsor MAYNE PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LEVORA 0.15/30-28 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.03MG;0.15MG No Yes
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 A073594-001 LEVORA 0.15/30-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073594-001 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 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A073594-001 LEVORA 0.15/30-28 0.03MG;0.15MG TABLET / ORAL-28 AB RS 1993-12-13 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 Levora LEVONORGESTREL AND ETHINYL ESTRADIOL Mayne Pharma Inc. 31679b9f-58c9-4bf1-8c2c-f5a216ff4cd3 2025-07-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073594 application number: ANDA073594 ndc (product): 51862-097
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 42254-260 Levora Levonorgestrel and Ethinyl Estradiol Rebel Distributors Corp ANDA Current 51862-097 Levora levonorgestrel and ethinyl estradiol Mayne Pharma Inc. ANDA Current 51862-097 Levora levonorgestrel and ethinyl estradiol Mayne Pharma Inc. ANDA Current 51862-097 Levora levonorgestrel and ethinyl estradiol Mayne Pharma Inc. ANDA Current 51862-097 Levora levonorgestrel and ethinyl estradiol Mayne Pharma Inc. ANDA Current 53002-1565 Levora levonorgestrel and ethinyl estradiol RPK Pharmaceuticals, Inc. ANDA Current 53002-1565 Levora levonorgestrel and ethinyl estradiol RPK Pharmaceuticals, Inc. ANDA Current