FDA.reportPublic FDA data

Application 017407

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CATAPRESCLONIDINE HYDROCHLORIDETABLET;ORAL0.1MGYesNo
002CATAPRESCLONIDINE HYDROCHLORIDETABLET;ORAL0.2MGYesNo
003CATAPRESCLONIDINE HYDROCHLORIDETABLET;ORAL0.3MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017407-001CATAPRESCLONIDINE HYDROCHLORIDE0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N017407-002CATAPRESCLONIDINE HYDROCHLORIDE0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N017407-003CATAPRESCLONIDINE HYDROCHLORIDE0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N017407-001CATAPRES0.1MGTABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N017407-002CATAPRES0.2MGTABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N017407-003CATAPRES0.3MGTABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017407-001CATAPRES0.1MGTABLET / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N017407-002CATAPRES0.2MGTABLET / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N017407-003CATAPRES0.3MGTABLET / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017407-001CATAPRES0.1MGTABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017407-002CATAPRES0.2MGTABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017407-003CATAPRES0.3MGTABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017407-001CATAPRES0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017407-002CATAPRES0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017407-003CATAPRES0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N017407-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N017407-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N017407-003AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017407-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017407-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017407-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N017407-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N017407-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N017407-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017407-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N017407-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N017407-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017407-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N017407-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N017407-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017407-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N017407-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N017407-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N017407-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N017407-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N017407-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017407-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N017407-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N017407-003AB1ea99ee380514…

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 · 109 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.6d7cfb02-e580-4658-a2fe-2149b515d4342026-09-09Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.00c6d67a-bb11-4884-9eeb-4e1b8701a08b2026-09-08Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.4b889e12-0382-4679-9cec-d6829c59e8532026-09-08Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
QLONILIKCLONIDINE HYDROCHLORIDECMP Pharma, Inc.826de1dc-378e-4c90-86d1-e33f7a4248cd2026-08-12Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDECoupler LLC58772b44-dec0-7001-e063-6394a90ac40e2026-08-07Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.e5d24f52-e0c2-428d-b647-481d63ffd95f2026-08-04Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDERedpharm Drug53df40e7-dd2b-d40e-e063-6394a90a21c42026-07-31Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEMajor Pharmaceuticals8171776a-dd14-4dcc-8860-3c27d8ea95042026-07-27Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.574640a5-829d-4e9d-be32-832a48cbd8dd2026-07-02Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.2a183d05-5be7-43e9-a084-700ec05d01e92026-07-02Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy32d72d7b-5881-f431-e063-6394a90a35472026-06-26Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEBryant Ranch Prepackcee049ea-a476-433c-971f-2466a6a3263b2026-06-24Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEBryant Ranch Prepackf65d90dc-11b4-4d63-b4a9-30603bc332ea2026-06-24Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEUnit Dose Solutions, Inc.547beb0f-0c12-2ef4-e063-6394a90a6a732026-06-17Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEUnit Dose Solutions, Inc.544ea5bf-6713-f034-e063-6394a90a781b2026-06-15Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.7ec53e25-c50a-48b4-82b0-c0b3626f31dc2026-06-01Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ea1527a5-4939-4ff7-a827-f88a9113a07d2026-05-26Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.be1b921d-152e-4bd5-82bd-56e2f8beef3e2026-05-26Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEASCLEMED USA INC.200afa03-adf3-4dca-8de8-1569701bd0292026-05-20Warnings, Adverse reactionsName fallback
generic name: CLONIDINE HYDROCHLORIDE
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDECoupler LLC266af0b1-ce85-6699-e063-6394a90acb4d2026-05-07Warnings, Adverse reactionsName fallback
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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0006Catapresclonidine hydrochlorideBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0006Catapresclonidine hydrochlorideBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0007Catapresclonidine hydrochlorideBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0007Catapresclonidine hydrochlorideBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0011Catapresclonidine hydrochlorideBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0011Catapresclonidine hydrochlorideBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10985SUPPL2012-06-06
13132SUPPL2012-06-05
10984SUPPL2010-04-19
13131SUPPL2010-04-09
33260SUPPL2010-01-08
577SUPPL2010-01-06
576SUPPL2010-01-06
10983SUPPL2009-11-13