Home Applications 071209 Application 071209
Type ANDA
Sponsor SANDOZ Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HALOPERIDOL HALOPERIDOL TABLET;ORAL 5MG No No 002 HALOPERIDOL HALOPERIDOL TABLET;ORAL 0.5MG No No 003 HALOPERIDOL HALOPERIDOL TABLET;ORAL 1MG No No 004 HALOPERIDOL HALOPERIDOL TABLET;ORAL 2MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071209-001 HALOPERIDOL HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 A071209-002 HALOPERIDOL HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 A071209-003 HALOPERIDOL HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 A071209-004 HALOPERIDOL HALOPERIDOL 2MG TABLET / ORAL 1986-11-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 139 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 2026-09-14 22:38:34 2026-08 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 107 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 5 of 5 · 82 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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0781-1396 Haloperidol Haloperidol Sandoz Inc ANDA Current 0781-1396 Haloperidol Haloperidol Sandoz Inc ANDA Current 0904-5925 Haloperidol Haloperidol Major Pharmaceuticals ANDA Current 21695-653 Haloperidol Haloperidol Rebel Distributors Corp ANDA Current 50090-2668 Haloperidol Haloperidol A-S Medication Solutions ANDA Current 50090-3365 Haloperidol Haloperidol A-S Medication Solutions ANDA Current 53808-0263 Haloperidol Haloperidol State of Florida DOH Central Pharmacy ANDA Current 55154-5414 Haloperidol Haloperidol Cardinal Health ANDA Current 63187-842 Haloperidol Haloperidol Proficient Rx LP ANDA Current 63187-842 Haloperidol Haloperidol Proficient Rx LP ANDA Current 70518-1529 Haloperidol Haloperidol REMEDYREPACK INC. ANDA Current 70518-1529 Haloperidol Haloperidol REMEDYREPACK INC. ANDA Current