FDA.reportPublic FDA data

Application 091104

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEINJECTABLE;INJECTION1MG/10ML (0.1MG/ML)NoNo
002CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEINJECTABLE;INJECTION5MG/10ML (0.5MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A091104-001CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-08
A091104-002CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-08

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-0884e616aacf4f…
2026-08-18 06:07:402026-07A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-0874a2ff9319b5…

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 6 of 6 · 113 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEAlembic Pharmaceuticals Limited88a8db46-0fc9-48cd-b7cc-ac9c9cdea1002023-01-27Warnings, Adverse reactionsName fallback
brand name: clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEAsclemed USA, Inc.e8c7aa08-1450-de68-e053-2995a90ad0b62022-09-16Warnings, Adverse reactionsName fallback
brand name: Clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEProficient Rx LP33c68d5e-6a68-40fd-a326-bf36a7e01d5b2022-09-01Warnings, Adverse reactionsName fallback
brand name: Clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEActavis Pharma, Inc.a842ab83-3531-44dd-a8a8-64dd89e870262022-09-01Warnings, Adverse reactionsName fallback
brand name: Clonidine Hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEProficient Rx LP38680c1d-3929-40d5-bda9-4eea5693afca2022-08-01Warnings, Adverse reactionsName fallback
brand name: clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.2a5b46ec-4c16-48a5-9e58-8d28a3f212742022-06-27Warnings, Adverse reactionsName fallback
brand name: Clonidine Hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEAurobindo Pharma Limited2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb2022-06-08Warnings, Adverse reactionsName fallback
brand name: Clonidine Hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
DuraclonCLONIDINE HYDROCHLORIDEMylan Institutional LLC8c126bb8-732a-4949-8754-2f50b55436382021-03-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEXiamen LP Pharmaceutical Co., Ltd.7676af27-4d8f-49c4-a50f-6b0892e73c8f2020-10-27Warnings, Adverse reactionsName fallback
brand name: Clonidine Hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEAsclemed USA, Inc.b60034a6-b8ba-4e54-9ef0-029965e67bc02020-10-24Warnings, Adverse reactionsName fallback
brand name: clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC00d1562d-b4eb-4d89-95de-0aacee7a82a52020-07-29Warnings, Adverse reactionsName fallback
brand name: Clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEProficient Rx LPc812012c-4b1d-40a4-8d4e-aaae2bf1c8522019-10-01Warnings, Adverse reactionsName fallback
brand name: clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCe9b22c56-a3fc-46df-b745-11c4ac309a912017-05-03Warnings, Adverse reactionsName fallback
brand name: Clonidine Hydrochloride
generic name: CLONIDINE HYDROCHLORIDE

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40042-052Clonidine HydrochlorideClonidine HydrochloridePharmaForce, Inc.ANDACurrent
40042-053Clonidine HydrochlorideClonidine HydrochloridePharmaForce, Inc.ANDACurrent