Home Applications 075288 Application 075288
Type ANDA
Sponsor MAYNE PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOW-OGESTREL-21 ETHINYL ESTRADIOL; NORGESTREL TABLET;ORAL-21 0.03MG;0.3MG No No 002 LOW-OGESTREL-28 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075288-001 LOW-OGESTREL-21 ETHINYL ESTRADIOL; NORGESTREL 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 A075288-002 LOW-OGESTREL-28 ETHINYL ESTRADIOL; NORGESTREL 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075288-002 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 3 · 82 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 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075288-001 LOW-OGESTREL-21 0.03MG;0.3MG TABLET / ORAL-21 1999-07-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075288-002 LOW-OGESTREL-28 0.03MG;0.3MG TABLET / ORAL-28 AB 1999-07-28 782e0a99824c…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51862-564 Low-Ogestrel Norgestrel and Ethinyl Estradiol Mayne Pharma Inc. ANDA Current 51862-564 Low-Ogestrel Norgestrel and Ethinyl Estradiol Mayne Pharma Inc. ANDA Current 51862-564 Low-Ogestrel Norgestrel and Ethinyl Estradiol Mayne Pharma Inc. ANDA Current 53002-1637 Low-Ogestrel Norgestrel and Ethinyl Estradiol RPK Pharmaceuticals, Inc. ANDA Current 53002-1637 Low-Ogestrel Norgestrel and Ethinyl Estradiol RPK Pharmaceuticals, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 42974 ORIG 2003-12-23 39476 ORIG 2003-12-23 8600 ORIG 1999-07-28