Home Applications 213317 Application 213317
Type ANDA
Sponsor CHEMO RESEARCH SL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GEMMILY ETHINYL ESTRADIOL; NORETHINDRONE ACETATE CAPSULE;ORAL 0.02MG;1MG No No
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 A213317-001 GEMMILY ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213317-001 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.
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 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 a50c72e98297…
Observed Orange Book normalized TE history# 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 Gemmily NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE Xiromed, LLC 6ca786fb-8f28-d2ac-5d8d-a14c3af6d7a7 2023-07-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213317 application number: ANDA213317 ndc (product): 70700-152
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16714-155 norethindrone acetate and ethinyl estradiol, and ferrous fumarate norethindrone acetate and ethinyl estradiol, and ferrous fumarate Northstar Rx LLC ANDA Current 70700-152 Gemmily norethindrone acetate and ethinyl estradiol, and ferrous fumarate Xiromed, LLC ANDA Current 70700-152 Gemmily norethindrone acetate and ethinyl estradiol, and ferrous fumarate Xiromed, LLC ANDA Current 70700-152 Gemmily norethindrone acetate and ethinyl estradiol, and ferrous fumarate Xiromed, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 65855 ORIG 2021-01-07