Home Applications 075406 Application 075406
Type ANDA
Sponsor WATSON LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OGESTREL 0.5/50-21 ETHINYL ESTRADIOL; NORGESTREL TABLET;ORAL-21 0.05MG;0.5MG No No 002 OGESTREL 0.5/50-28 ETHINYL ESTRADIOL; NORGESTREL TABLET;ORAL-28 0.05MG;0.5MG No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A075406-001 OGESTREL 0.5/50-21 ETHINYL ESTRADIOL; NORGESTREL 0.05MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 1999-12-15 A075406-002 OGESTREL 0.5/50-28 ETHINYL ESTRADIOL; NORGESTREL 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15
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 2 of 3 · 88 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 2019-12-13 00:20 UTC 2019-12 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 RS 1999-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 RS 1999-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 RS 1999-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 RS 1999-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 RS 1999-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 1999-12-15 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 1999-12-15 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 1999-12-15 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 3a93d1ddd44b…
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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 52544-848 Ogestrel Norgestrel and Ethinyl Estradiol Actavis Pharma, Inc. ANDA Current 52544-848 Ogestrel Norgestrel and Ethinyl Estradiol Actavis Pharma, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8654 SUPPL 2013-04-24 39484 SUPPL 2013-04-23 30874 ORIG 1999-12-15