Home Applications 078193 Application 078193
Type ANDA
Sponsor TEVA PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE TABLET;ORAL 60MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A078193-001 RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078193-001 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 · 44 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 2026-10-15 13:18:30 2026-09 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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.
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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0093-7290 Raloxifene Hydrochloride Raloxifene Hydrochloride Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7290 Raloxifene Hydrochloride Raloxifene Hydrochloride Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7290 Raloxifene Hydrochloride Raloxifene Hydrochloride Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7290 Raloxifene Hydrochloride Raloxifene Hydrochloride Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7290 Raloxifene Hydrochloride Raloxifene Hydrochloride Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7290 Raloxifene Hydrochloride Raloxifene Hydrochloride Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7290 Raloxifene Hydrochloride Raloxifene Hydrochloride Teva Pharmaceuticals USA, Inc. ANDA Current 42291-726 Raloxifene Hydrochloride Raloxifene Hydrochloride AvKARE, Inc. ANDA Current 42291-726 Raloxifene Hydrochloride Raloxifene Hydrochloride AvKARE ANDA Current 68071-2412 Raloxifene Hydrochloride Raloxifene Hydrochloride NuCare Pharmaceuticals,Inc. ANDA Current 70518-2994 Raloxifene Hydrochloride Raloxifene Hydrochloride REMEDYREPACK INC. ANDA Current 71335-1715 Raloxifene Hydrochloride Raloxifene Hydrochloride Bryant Ranch Prepack ANDA Current 71335-1715 Raloxifene Hydrochloride Raloxifene Hydrochloride Bryant Ranch Prepack ANDA Current 71610-504 Raloxifene Hydrochloride Raloxifene Hydrochloride Aphena Pharma Solutions - Tennessee, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 52769 ORIG 2018-02-28 9129 ORIG 2014-03-06