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 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
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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091104-001CLONIDINE 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…
2022-03-09 01:35 UTC2022-03A091104-001CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML)INJECTABLE / INJECTION2009-10-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091104-002CLONIDINE HYDROCHLORIDE5MG/10ML (0.5MG/ML)INJECTABLE / INJECTION2009-10-08bb7c543d1eb4…

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 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
clonidine hydrochlorideCLONIDINE HYDROCHLORIDECoupler LLC58772b44-dec0-7001-e063-6394a90ac40e2026-08-07Warnings, Adverse reactionsName fallback
brand name: clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.e5d24f52-e0c2-428d-b647-481d63ffd95f2026-08-04Warnings, Adverse reactionsName fallback
brand name: clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDERedpharm Drug53df40e7-dd2b-d40e-e063-6394a90a21c42026-07-31Warnings, Adverse reactionsName fallback
brand name: clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEMajor Pharmaceuticals8171776a-dd14-4dcc-8860-3c27d8ea95042026-07-27Warnings, Adverse reactionsName fallback
brand name: Clonidine Hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.e96ab74c-eedf-4d71-8a35-d5ec3daa75922026-07-21Warnings, Adverse reactionsName fallback
brand name: clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.574640a5-829d-4e9d-be32-832a48cbd8dd2026-07-02Warnings, Adverse reactionsName fallback
brand name: clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.2a183d05-5be7-43e9-a084-700ec05d01e92026-07-02Warnings, Adverse reactionsName fallback
brand name: clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy32d72d7b-5881-f431-e063-6394a90a35472026-06-26Warnings, Adverse reactionsName fallback
brand name: clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEBryant Ranch Prepackcee049ea-a476-433c-971f-2466a6a3263b2026-06-24Warnings, Adverse reactionsName fallback
brand name: Clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEBryant Ranch Prepackf65d90dc-11b4-4d63-b4a9-30603bc332ea2026-06-24Warnings, Adverse reactionsName fallback
brand name: Clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEUnit Dose Solutions, Inc.547beb0f-0c12-2ef4-e063-6394a90a6a732026-06-17Warnings, Adverse reactionsName fallback
brand name: Clonidine Hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEUnit Dose Solutions, Inc.544ea5bf-6713-f034-e063-6394a90a781b2026-06-15Warnings, Adverse reactionsName fallback
brand name: Clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.7ec53e25-c50a-48b4-82b0-c0b3626f31dc2026-06-01Warnings, Adverse reactionsName fallback
brand name: Clonidine Hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ea1527a5-4939-4ff7-a827-f88a9113a07d2026-05-26Warnings, Adverse reactionsName fallback
brand name: clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.be1b921d-152e-4bd5-82bd-56e2f8beef3e2026-05-26Warnings, Adverse reactionsName fallback
brand name: clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEASCLEMED USA INC.200afa03-adf3-4dca-8de8-1569701bd0292026-05-20Warnings, Adverse reactionsName fallback
brand name: clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDECoupler LLC266af0b1-ce85-6699-e063-6394a90acb4d2026-05-07Warnings, Adverse reactionsName fallback
brand name: Clonidine Hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy666e757e-9b43-2e40-e053-2991aa0a59a22026-05-05Warnings, Adverse reactionsName fallback
brand name: clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.50c8a725-a449-256b-e063-6294a90a3e442026-05-01Warnings, Adverse reactionsName fallback
brand name: Clonidine hydrochloride
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDECardinal Health 107, LLCdf62817d-2f50-4c27-aaa8-a22f0290c94f2026-05-01Warnings, Adverse reactionsName fallback
brand name: Clonidine Hydrochloride
generic name: CLONIDINE HYDROCHLORIDE

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