Home Applications 075440 Application 075440
Type ANDA
Sponsor MYLAN LABS LTD 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 42 .
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 A075440-001 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 A075440-002 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28
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 · 84 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 2026-08-18 06:07:40 2026-07 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075440-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075440-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2000-02-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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.
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 67457-381 Haloperidol Decanoate Haloperidol Decanoate Mylan Institutional LLC ANDA Current 67457-381 Haloperidol Decanoate Haloperidol Decanoate Mylan Institutional LLC ANDA Current 67457-381 Haloperidol Decanoate Haloperidol Decanoate Mylan Institutional LLC ANDA Current 67457-381 Haloperidol Decanoate Haloperidol Decanoate Mylan Institutional LLC ANDA Current 67457-409 Haloperidol Decanoate Haloperidol Decanoate Mylan Institutional LLC ANDA Current 67457-409 Haloperidol Decanoate Haloperidol Decanoate Mylan Institutional LLC ANDA Current 67457-409 Haloperidol Decanoate Haloperidol Decanoate Mylan Institutional LLC ANDA Current 67457-409 Haloperidol Decanoate Haloperidol Decanoate Mylan Institutional LLC ANDA Current 67457-410 Haloperidol Decanoate Haloperidol Decanoate Mylan Institutional LLC ANDA Current 67457-410 Haloperidol Decanoate Haloperidol Decanoate Mylan Institutional LLC ANDA Current 67457-410 Haloperidol Decanoate Haloperidol Decanoate Mylan Institutional LLC ANDA Current 67457-410 Haloperidol Decanoate Haloperidol Decanoate Mylan Institutional LLC ANDA Current 70518-1809 Haloperidol Decanoate Haloperidol Decanoate REMEDYREPACK INC. ANDA Current 70518-1809 Haloperidol Decanoate Haloperidol Decanoate REMEDYREPACK INC. ANDA Current 70518-1809 Haloperidol Decanoate Haloperidol Decanoate REMEDYREPACK INC. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8672 SUPPL 2008-01-09 22473 ORIG 2007-07-09 8671 ORIG 2000-02-28