Home Applications 209101 Application 209101
Type ANDA
Sponsor SOMERSET THERAPS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 50MG BASE/ML No No 002 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 100MG BASE/ML 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 A209101-001 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 A209101-002 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03
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 1 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 2026-10-15 13:18:30 2026-09 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209101-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209101-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2018-07-03 4b0b4de00fa7…
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.
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 · 44 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70069-030 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-030 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-030 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LL ANDA Current 70069-030 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-030 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-030 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-030 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-031 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-031 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-031 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LL ANDA Current 70069-031 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-031 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-031 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-031 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-381 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-381 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-381 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-381 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-381 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-381 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-382 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-382 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-382 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-382 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-382 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-382 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-383 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-383 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-383 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-383 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-383 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-383 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-384 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-384 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-384 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-384 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-384 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70069-384 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE Somerset Therapeutics, LLC ANDA Current 70518-2520 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE REMEDYREPACK INC. ANDA Current 70518-2520 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE REMEDYREPACK INC. ANDA Current 70518-2520 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE REMEDYREPACK INC. ANDA Current 70518-2520 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE REMEDYREPACK INC. ANDA Current 70518-3170 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE REMEDYREPACK INC. ANDA Current 70518-3170 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE REMEDYREPACK INC. ANDA Current