Home Applications 207261 Application 207261
Type ANDA
Sponsor MYLAN LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.5MG;0.1MG No No 002 ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 1MG;0.5MG No No
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 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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 ABIGALE LO ESTRADIOL AND NORETHINDRONE ACETATE Xiromed LLC df013d36-de10-0607-7e12-95ed43bf7ee9 2024-09-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207261 application number: ANDA207261
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-7294 ESTRADIOL AND NORETHINDRONE ACETATE estradiol and norethindrone acetate Mylan Pharmaceuticals Inc. ANDA Current 0378-7294 ESTRADIOL AND NORETHINDRONE ACETATE estradiol and norethindrone acetate Mylan Pharmaceuticals Inc. ANDA Current 0378-7294 ESTRADIOL AND NORETHINDRONE ACETATE estradiol and norethindrone acetate Mylan Pharmaceuticals Inc. ANDA Current 0378-7295 ESTRADIOL AND NORETHINDRONE ACETATE estradiol and norethindrone acetate Mylan Pharmaceuticals Inc. ANDA Current 0378-7295 ESTRADIOL AND NORETHINDRONE ACETATE estradiol and norethindrone acetate Mylan Pharmaceuticals Inc. ANDA Current 0378-7295 ESTRADIOL AND NORETHINDRONE ACETATE estradiol and norethindrone acetate Mylan Pharmaceuticals Inc. ANDA Current