Application 072124

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDETABLET;ORAL80MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072124-001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-2684e616aacf4f…
2026-08-18 06:07:402026-07A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-263f01610625f2…
2019-09-15 20:21 UTC2019-09A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072124-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORAL1989-01-26f41ea6bd6efb…

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 5 of 5 · 93 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ed1e0c14-3571-43f9-88fc-5a4d2b5982632022-03-12Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEMylan Pharmaceuticals Inc.c86084bc-33aa-eece-5a96-6c0dad2d1a322021-06-21Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEGland Pharma Limitedeb3c66f6-581f-422b-9ca2-9b877b323a332020-10-19Warnings, Adverse reactionsName fallback
brand name: Verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC2712ab16-122b-4f44-a687-e2cb3c04019e2020-04-09Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEBaxter Healthcare Corporation03c5daf8-5399-4d89-a747-9a9d7667b6e42020-03-25Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEArmas Pharmaceuticals Inc.2d595d9d-af88-474d-b622-d63d786f06a72020-01-08Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEArmas Pharmaceuticals Inc.51597adb-bfb1-4611-b577-8989724fc3a42020-01-04Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEProficient Rx LP19cb23bd-cc6d-45fc-a1fc-b4130ea460a62019-11-01Warnings, Adverse reactionsName fallback
brand name: verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEProficient Rx LPa6de732a-fe48-486d-bb05-0a9fff6f42d72019-10-01Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEProficient Rx LP4ffa579e-1d85-4b3b-ae06-6a9334e0f9e12019-10-01Warnings, Adverse reactionsName fallback
brand name: verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc635f442-2349-4820-877a-a42e5f0a44b52019-05-08Warnings, Adverse reactionsName fallback
brand name: verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEEXELA PHARMA SCIENCES, LLCeff5e83b-f819-4a5b-9746-12bce328d7a72017-02-21Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEEXELA PHARMA SCIENCES, LLC3318e357-0660-44f4-8170-91a51bd762fb2017-01-23Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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