Home Applications 209714 Application 209714
Type ANDA
Sponsor HBT LABS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FULVESTRANT FULVESTRANT INJECTABLE;INTRAMUSCULAR 50MG/ML 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 A209714-001 FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209714-001 AO
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 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209714-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209714-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209714-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-11-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209714-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209714-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-11-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209714-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-11-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209714-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-11-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209714-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-11-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209714-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-11-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209714-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-11-21 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209714-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-11-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209714-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-11-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209714-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-11-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209714-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-11-21 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70534-002 fulvestrant fulvestrant HBT Labs, Inc. ANDA Current 70534-002 fulvestrant fulvestrant HBT Labs, Inc. ANDA Current 70534-002 fulvestrant fulvestrant HBT Labs, Inc. ANDA Current 70534-002 fulvestrant fulvestrant HBT Labs, Inc. ANDA Current 70534-002 fulvestrant fulvestrant HBT Labs, Inc. ANDA Current 70534-002 fulvestrant fulvestrant HBT Labs, Inc. ANDA Current 71288-555 Fulvestrant Fulvestrant Meitheal Pharmaceuticals Inc ANDA Current 71288-555 Fulvestrant Fulvestrant Meitheal Pharmaceuticals Inc ANDA Current 71288-555 Fulvestrant Fulvestrant Meitheal Pharmaceuticals Inc ANDA Current 71288-555 Fulvestrant Fulvestrant Meitheal Pharmaceuticals Inc ANDA Current 72603-105 Fulvestrant Fulvestrant NorthStar Rx LLC ANDA Current 72603-105 Fulvestrant Fulvestrant NorthStar Rx LLC ANDA Current 72603-105 Fulvestrant Fulvestrant NorthStar Rx LLC ANDA Current 72603-105 Fulvestrant Fulvestrant NorthStar Rx LLC ANDA Current 72603-105 Fulvestrant Fulvestrant NorthStar Rx LLC ANDA Current