Application 075393
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075393-001 | HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | ||
| A075393-002 | HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 |
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 | 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 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | 1999-05-11 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AO | 1999-05-11 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AO | 1999-05-11 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AO | 1999-05-11 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AO | 1999-05-11 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AO | 1999-05-11 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AO | 1999-05-11 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AO | 1999-05-11 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AO | 1999-05-11 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075393-001 | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AO | 1999-05-11 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075393-002 | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AO | 1999-05-11 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075393-001 | AO | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075393-002 | AO | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075393-001 | AO | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075393-002 | AO | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075393-001 | AO | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075393-002 | AO | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075393-001 | AO | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075393-002 | AO | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075393-001 | AO | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075393-002 | AO | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075393-001 | AO | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A075393-002 | AO | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075393-001 | AO | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075393-002 | AO | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A075393-001 | AO | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A075393-002 | AO | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A075393-001 | AO | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A075393-002 | AO | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A075393-001 | AO | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A075393-002 | AO | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A075393-001 | AO | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A075393-002 | AO | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A075393-001 | AO | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A075393-002 | AO | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A075393-001 | AO | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075393-002 | AO | 1 | ea99ee380514… |
| 2023-12-20 04:57 UTC | 2023-12 | A075393-001 | AO | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A075393-002 | AO | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075393-001 | AO | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075393-002 | AO | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075393-001 | AO | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075393-002 | AO | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075393-001 | AO | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075393-002 | AO | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075393-001 | AO | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075393-002 | AO | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A075393-001 | AO | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A075393-002 | AO | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A075393-001 | AO | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A075393-002 | AO | 1 | 3bdfa0b2c4d7… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Haloperidol Decanoate | HALOPERIDOL DECANOATE | Gland Pharma Limited | 1a0e38cb-fd9f-4962-9f81-5c0023ca6b4c | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | Haloperidol Decanoate HALOPERIDOL DECANOATE |
| Haloperidol decanoate | HALOPERIDOL DECANOATE | Zydus Pharmaceuticals USA Inc. | 6d2d7612-ad47-4ee7-a42c-945c976d947b | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | Haloperidol decanoate HALOPERIDOL DECANOATE |
| Haloperidol Decanoate | HALOPERIDOL DECANOATE | NorthStar RxLLC | b83cb022-cfeb-4492-927b-0b461f7201d4 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | Haloperidol Decanoate HALOPERIDOL DECANOATE |
| Haloperidol Decanoate | HALOPERIDOL DECANOATE | Lifestar Pharma LLC | 8a96195e-97cd-4161-96e0-494a1636fa9c | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | Haloperidol Decanoate HALOPERIDOL DECANOATE |
| Haloperidol Decanoate | HALOPERIDOL DECANOATE | REMEDYREPACK INC. | 4a3653df-84c7-46c2-b8fd-28c63cd2747a | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | Haloperidol Decanoate HALOPERIDOL DECANOATE |
| Haloperidol Decanoate | HALOPERIDOL DECANOATE | REMEDYREPACK INC. | 530f440f-d4e8-423a-99a2-02d02e794ccb | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | Haloperidol Decanoate HALOPERIDOL DECANOATE |
| Haloperidol Decanoate | HALOPERIDOL DECANOATE | Armas Pharmaceuticals Inc. | 80d51d2c-30e4-4eef-b184-0cebb30ca429 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | Haloperidol Decanoate HALOPERIDOL DECANOATE |
| Haloperidol Decanoate | HALOPERIDOL DECANOATE | Armas Pharmaceuticals Inc. | 9979e28f-2716-4788-8605-16f6edf158b5 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | Haloperidol Decanoate HALOPERIDOL DECANOATE |
| Haloperidol Decanoate | HALOPERIDOL DECANOATE | Meitheal Pharmaceuticals Inc. | 14f40303-9604-4a30-8e86-8abaeb177ce1 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | Haloperidol Decanoate HALOPERIDOL DECANOATE |
| Haloperidol decanoate | HALOPERIDOL DECANOATE | BluePoint Laboratories | 3d011250-a517-4c27-8ce3-d59d441ea61c | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | Haloperidol decanoate HALOPERIDOL DECANOATE |
| Haloperidol Decanoate | HALOPERIDOL DECANOATE | REMEDYREPACK INC. | 15b82169-882b-40ef-bbda-5adc3e7eb930 | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | Haloperidol Decanoate HALOPERIDOL DECANOATE |
| Haloperidol Decanoate | HALOPERIDOL DECANOATE | Mylan Institutional LLC | 8ffac6fb-1702-40d6-b085-152d24673cbd | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | Haloperidol Decanoate HALOPERIDOL DECANOATE |
| Haldol Decanoate | HALOPERIDOL DECANOATE | Janssen Pharmaceuticals, Inc. | af0159a8-dff5-449a-aa2b-a0c430081e21 | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | HALOPERIDOL DECANOATE |
| Haloperidol Decanoate | HALOPERIDOL DECANOATE | REMEDYREPACK INC. | 2cdd9fca-afe5-4bfa-8db1-337beec13c6b | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | Haloperidol Decanoate HALOPERIDOL DECANOATE |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | Somerset Therapeutics, LLC | 068fc913-779d-44c6-9585-3aa80e751bee | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE |
| Haloperidol Decanoate | HALOPERIDOL DECANOATE | Caplin Steriles Limited | 4f9af14a-38c4-4826-aca0-3501edb854e3 | 2025-05-26 | Boxed warning, Warnings, Adverse reactions | Haloperidol Decanoate HALOPERIDOL DECANOATE |
| Haloperidol Decanoate | HALOPERIDOL DECANOATE | Armas Pharmaceuticals Inc. | f9876b88-3caa-4c08-9a59-9b4a455e101d | 2025-05-26 | Boxed warning, Warnings, Adverse reactions | Haloperidol Decanoate HALOPERIDOL DECANOATE |
| Haloperidol Decanoate | HALOPERIDOL DECANOATE | Patriot Pharmaceuticals LLC | 9f0f42a8-5f7c-4be7-93ef-3ec225502cc6 | 2025-02-19 | Boxed warning, Warnings, Adverse reactions | Haloperidol Decanoate HALOPERIDOL DECANOATE |
| Haloperidol Decanoate | HALOPERIDOL DECANOATE | Hikma Pharmaceuticals USA Inc. | 914026da-103a-4466-abd5-3763e9d55b67 | 2024-12-12 | Boxed warning, Warnings, Adverse reactions | Haloperidol Decanoate HALOPERIDOL DECANOATE |
| haloperidol decanoate | HALOPERIDOL DECANOATE | Sagent Pharmaceuticals | b3167043-585f-482f-b8a7-591bc2721bd3 | 2024-02-27 | Boxed warning, Warnings, Adverse reactions | haloperidol decanoate HALOPERIDOL DECANOATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0703-7011 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7011 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7011 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7011 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7011 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7013 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7013 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7013 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7013 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7013 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7021 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7021 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7021 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7021 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7021 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7023 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7023 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7023 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7023 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7023 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7121 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7121 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7121 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7123 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7123 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7123 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7131 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7131 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7131 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7133 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7133 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-7133 | Haloperidol Decanoate | Haloperidol Decanoate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 70518-3097 | Haloperidol Decanoate | Haloperidol Decanoate | REMEDYREPACK INC. | ANDA | Current |