Home Applications 091452 Application 091452
Type ANDA
Sponsor GLENMARK GENERICS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MARLISSA ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.03MG;0.15MG 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 A091452-001 MARLISSA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091452-001 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 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 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 MARLISSA LEVONORGESTREL AND ETHINYL ESTRADIOL Glenmark Pharmaceuticals Inc., USA 9379d99e-c416-4dab-a817-1c110e0d4b93 2026-01-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091452 application number: ANDA091452 ndc (product): 68462-388
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50090-1392 MARLISSA Levonorgestrel and Ethinyl Estradiol A-S Medication Solutions ANDA Current 50090-1392 MARLISSA Levonorgestrel and Ethinyl Estradiol A-S Medication Solutions ANDA Current 68462-388 MARLISSA Levonorgestrel and Ethinyl Estradiol Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-388 MARLISSA Levonorgestrel and Ethinyl Estradiol Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-388 MARLISSA Levonorgestrel and Ethinyl Estradiol Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-388 MARLISSA Levonorgestrel and Ethinyl Estradiol Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-388 MARLISSA Levonorgestrel and Ethinyl Estradiol Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-388 MARLISSA Levonorgestrel and Ethinyl Estradiol Glenmark Pharmaceuticals Inc., USA ANDA Current 68788-6339 MARLISSA Levonorgestrel and Ethinyl Estradiol Preferreed Pharmaceuticals Inc. ANDA Current 68788-6339 MARLISSA Levonorgestrel and Ethinyl Estradiol Preferreed Pharmaceuticals Inc. ANDA Current 68788-6339 MARLISSA Levonorgestrel and Ethinyl Estradiol Preferreed Pharmaceuticals Inc. ANDA Current