FDA.reportPublic FDA data

Application 020552

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COVERA-HSVERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL180MGNoNo
002COVERA-HSVERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL240MGNoNo

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

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
N020552-001COVERA-HSVERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORAL1996-02-26
N020552-002COVERA-HSVERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORAL1996-02-26

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020552-001COVERA-HS180MGTABLET, EXTENDED RELEASE / ORAL1996-02-26f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N020552-002COVERA-HS240MGTABLET, EXTENDED RELEASE / ORAL1996-02-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020552-001COVERA-HS180MGTABLET, EXTENDED RELEASE / ORAL1996-02-26e64feba35796…
2022-09-29 23:25 UTC2022-09N020552-002COVERA-HS240MGTABLET, EXTENDED RELEASE / ORAL1996-02-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020552-001COVERA-HS180MGTABLET, EXTENDED RELEASE / ORAL1996-02-26cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020552-002COVERA-HS240MGTABLET, EXTENDED RELEASE / ORAL1996-02-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020552-001COVERA-HS180MGTABLET, EXTENDED RELEASE / ORAL1996-02-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020552-002COVERA-HS240MGTABLET, EXTENDED RELEASE / ORAL1996-02-26a50c72e98297…

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 5 · 90 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEMicro Labs Limited9c89764e-ff07-4077-a40f-91eb1c179af22026-08-18Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEA-S Medication Solutionsed182ebe-8299-4680-9dea-ef79d30db6832026-08-18Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstdf79ee3a-f0ed-1cc7-e053-2995a90af97f2026-07-23Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDELifestar Pharma LLCdf77b8d1-1d2b-4fea-a1e9-153bd25008a62026-07-10Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHospira, Inc.1c993365-1b62-4524-e781-d307f28f63bc2026-07-09Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEREMEDYREPACK INC.ce9ab27a-e03b-4e40-a0e0-b586cd75dead2026-06-29Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDESomerset Therapeutics, LLC50131bbc-ad43-4708-946f-e4000828137c2026-06-24Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDESafecor Health LLCbf7b5037-7355-4788-b17b-323c18a5aee72026-06-23Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHenry Schein, Inc.4f6ae43f-c28a-4eac-9b19-8b5d0c12dfaa2026-06-19Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEREMEDYREPACK INC.5dc5f087-c8da-4ed0-b532-ae44508958aa2026-06-01Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDENivagen Pharmaceuticals, Inc.e36e485f-fbed-4e30-9a63-984931f2e54e2026-05-13Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst4dcc46d8-76b0-fbd4-e063-6294a90ad9e62026-05-05Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHospira, Inc.70057a53-ca29-4848-ab3d-5e691e2a14a32026-04-29Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEZydus Lifesciences Limited051392d3-8ec1-450c-8c38-791d4ef1a2db2026-04-09Name fallback
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.e19ab8d8-dae5-489d-9805-7e7407bea06d2026-04-06Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst4dcb137e-b01a-eb3a-e063-6294a90aaecc2026-03-24Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEBryant Ranch Prepack1de6ad5c-942e-4381-b01f-e5e63bbf72ef2026-03-10Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEA-S Medication Solutionse07b3574-9259-4f64-a9ae-f4e0e64800b62026-03-07Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDECadila Pharmaceuticals Limited5501208c-aa2b-47aa-89f7-87f4d4a73fd02026-02-09Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEAvKAREa32f346e-71cf-cc11-e053-2a95a90ae88c2026-01-15Warnings, Adverse reactionsName fallback
generic name: VERAPAMIL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49782SUPPL2017-09-19
49763SUPPL2017-09-18
45231SUPPL2016-08-24
2713SUPPL2011-11-07
12718SUPPL2011-11-04
34815SUPPL2010-04-30
2712SUPPL2010-04-21
2711SUPPL2009-07-07
12717SUPPL2009-06-30
2710SUPPL2004-06-02