Application 075393

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEINJECTABLE;INJECTIONEQ 50MG BASE/MLNoNo
002HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEINJECTABLE;INJECTIONEQ 100MG BASE/MLNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075393-001HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-11
A075393-002HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-11

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTION1999-05-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTION1999-05-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO1999-05-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO1999-05-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO1999-05-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO1999-05-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO1999-05-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO1999-05-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO1999-05-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO1999-05-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075393-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO1999-05-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075393-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO1999-05-11bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075393-001AO15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075393-002AO15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075393-001AO15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075393-002AO15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075393-001AO14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075393-002AO14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075393-001AO174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075393-002AO174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075393-001AO1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075393-002AO1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075393-001AO1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075393-002AO1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075393-001AO187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075393-002AO187673890dc5c…
2021-03-12 10:30 UTC2021-03A075393-001AO15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075393-002AO15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075393-001AO18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075393-002AO18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075393-001AO1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075393-002AO1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075393-001AO13f01610625f2…
2019-12-14 00:12 UTC2019-12A075393-002AO13f01610625f2…
2019-09-15 20:21 UTC2019-09A075393-001AO1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075393-002AO1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075393-001AO1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075393-002AO1ea99ee380514…
2023-12-20 04:57 UTC2023-12A075393-001AO1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A075393-002AO1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075393-001AO1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075393-002AO1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075393-001AO19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075393-002AO19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075393-001AO1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075393-002AO1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075393-001AO13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075393-002AO13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075393-001AO1053a50430f4f…
2023-05-13 08:27 UTC2023-05A075393-002AO1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075393-001AO13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A075393-002AO13bdfa0b2c4d7…

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Haloperidol DecanoateHALOPERIDOL DECANOATEGland Pharma Limited1a0e38cb-fd9f-4962-9f81-5c0023ca6b4c2026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol Decanoate
generic name: HALOPERIDOL DECANOATE
Haloperidol decanoateHALOPERIDOL DECANOATEZydus Pharmaceuticals USA Inc.6d2d7612-ad47-4ee7-a42c-945c976d947b2026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol decanoate
generic name: HALOPERIDOL DECANOATE
Haloperidol DecanoateHALOPERIDOL DECANOATENorthStar RxLLCb83cb022-cfeb-4492-927b-0b461f7201d42026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol Decanoate
generic name: HALOPERIDOL DECANOATE
Haloperidol DecanoateHALOPERIDOL DECANOATELifestar Pharma LLC8a96195e-97cd-4161-96e0-494a1636fa9c2026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol Decanoate
generic name: HALOPERIDOL DECANOATE
Haloperidol DecanoateHALOPERIDOL DECANOATEREMEDYREPACK INC.4a3653df-84c7-46c2-b8fd-28c63cd2747a2026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol Decanoate
generic name: HALOPERIDOL DECANOATE
Haloperidol DecanoateHALOPERIDOL DECANOATEREMEDYREPACK INC.530f440f-d4e8-423a-99a2-02d02e794ccb2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol Decanoate
generic name: HALOPERIDOL DECANOATE
Haloperidol DecanoateHALOPERIDOL DECANOATEArmas Pharmaceuticals Inc.80d51d2c-30e4-4eef-b184-0cebb30ca4292026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol Decanoate
generic name: HALOPERIDOL DECANOATE
Haloperidol DecanoateHALOPERIDOL DECANOATEArmas Pharmaceuticals Inc.9979e28f-2716-4788-8605-16f6edf158b52026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol Decanoate
generic name: HALOPERIDOL DECANOATE
Haloperidol DecanoateHALOPERIDOL DECANOATEMeitheal Pharmaceuticals Inc.14f40303-9604-4a30-8e86-8abaeb177ce12026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol Decanoate
generic name: HALOPERIDOL DECANOATE
Haloperidol decanoateHALOPERIDOL DECANOATEBluePoint Laboratories3d011250-a517-4c27-8ce3-d59d441ea61c2026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol decanoate
generic name: HALOPERIDOL DECANOATE
Haloperidol DecanoateHALOPERIDOL DECANOATEREMEDYREPACK INC.15b82169-882b-40ef-bbda-5adc3e7eb9302026-03-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol Decanoate
generic name: HALOPERIDOL DECANOATE
Haloperidol DecanoateHALOPERIDOL DECANOATEMylan Institutional LLC8ffac6fb-1702-40d6-b085-152d24673cbd2026-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol Decanoate
generic name: HALOPERIDOL DECANOATE
Haldol DecanoateHALOPERIDOL DECANOATEJanssen Pharmaceuticals, Inc.af0159a8-dff5-449a-aa2b-a0c430081e212025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HALOPERIDOL DECANOATE
Haloperidol DecanoateHALOPERIDOL DECANOATEREMEDYREPACK INC.2cdd9fca-afe5-4bfa-8db1-337beec13c6b2025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol Decanoate
generic name: HALOPERIDOL DECANOATE
HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLC068fc913-779d-44c6-9585-3aa80e751bee2025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: HALOPERIDOL DECANOATE
generic name: HALOPERIDOL DECANOATE
Haloperidol DecanoateHALOPERIDOL DECANOATECaplin Steriles Limited4f9af14a-38c4-4826-aca0-3501edb854e32025-05-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol Decanoate
generic name: HALOPERIDOL DECANOATE
Haloperidol DecanoateHALOPERIDOL DECANOATEArmas Pharmaceuticals Inc.f9876b88-3caa-4c08-9a59-9b4a455e101d2025-05-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol Decanoate
generic name: HALOPERIDOL DECANOATE
Haloperidol DecanoateHALOPERIDOL DECANOATEPatriot Pharmaceuticals LLC9f0f42a8-5f7c-4be7-93ef-3ec225502cc62025-02-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol Decanoate
generic name: HALOPERIDOL DECANOATE
Haloperidol DecanoateHALOPERIDOL DECANOATEHikma Pharmaceuticals USA Inc.914026da-103a-4466-abd5-3763e9d55b672024-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Haloperidol Decanoate
generic name: HALOPERIDOL DECANOATE
haloperidol decanoateHALOPERIDOL DECANOATESagent Pharmaceuticalsb3167043-585f-482f-b8a7-591bc2721bd32024-02-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: haloperidol decanoate
generic name: HALOPERIDOL DECANOATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-7011Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7011Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7011Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7011Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7011Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7013Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7013Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7013Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7013Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7013Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7021Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7021Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7021Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7021Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7021Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7023Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7023Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7023Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7023Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7023Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7121Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7121Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7121Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7123Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7123Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7123Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7131Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7131Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7131Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7133Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7133Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7133Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
70518-3097Haloperidol DecanoateHaloperidol DecanoateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42990ORIG1999-05-11
8645ORIG1999-05-11