Application 213352

Type
ANDA
Sponsor
AREVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDESOLUTION;INTRAVENOUS10MG/4ML (2.5MG/ML)NoNo
002VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDESOLUTION;INTRAVENOUS5MG/2ML (2.5MG/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
A213352-001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-17
A213352-002VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A213352-001AP
A213352-002AP

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 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-1784e616aacf4f…
2026-09-14 22:38:342026-08A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-1684e616aacf4f…
2026-08-18 06:07:402026-07A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-164b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-16bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213352-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A213352-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A213352-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A213352-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213352-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213352-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213352-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213352-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213352-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213352-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213352-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213352-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213352-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213352-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213352-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213352-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213352-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213352-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213352-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213352-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213352-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213352-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213352-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213352-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213352-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213352-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213352-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213352-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213352-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213352-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213352-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213352-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213352-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213352-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213352-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213352-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213352-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213352-002AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213352-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213352-002AP1bb7c543d1eb4…

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 3 of 5 · 93 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEGolden State Medical Supply, Inc.3283bba6-05dd-3766-e063-6394a90ada692025-04-11Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEChartwell RX, LLC18f6d349-8c5c-4443-ac65-16bf6619ecdc2025-03-25Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.fe0583bf-9986-e01e-e053-6294a90a0b262025-02-04Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.fe05b8d8-fdee-903b-e053-6394a90a2e052025-02-04Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.febce7aa-7f5a-e0c1-e053-6394a90aebc42025-02-04Warnings, Adverse reactionsName fallback
brand name: verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDECaplin Steriles Limitede18cc04c-a808-4d92-9b66-762cd787abc52025-01-16Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.d23c757d-39f8-48c3-ba63-df2cbe58c5162025-01-09Warnings, Adverse reactionsName fallback
brand name: verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1076a3ef-de02-487f-8117-b4e80495db292024-12-26Warnings, Adverse reactionsName fallback
brand name: Verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.fdb7cd57-d33c-f5a3-e053-6294a90aff312024-12-13Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEZydus Pharmaceuticals USA Inc.a9a1a522-231b-41a1-95c6-0c75dbb62f472024-12-06Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEZydus Pharmaceuticals USA Inc.c87c7f7e-cdf5-42c7-a831-a7515d2d51d62024-12-06Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEWilshire Pharmaceuticals, Inc.5f665d08-e1e4-422a-88c2-d8834abf9e1a2024-11-27Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEWilshire Pharmaceuticals, Inc.f9399858-fd7a-4b73-8759-3e5bf3af26662024-11-27Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEFRESENIUS KABI USA, LLC38ca9270-5538-467a-a3e9-c27968f3aafe2024-11-08Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEBryant Ranch Prepack660a83a9-60be-42d5-bc70-fe384e93beaa2024-10-24Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEA-S Medication Solutions0b00ec93-0bb3-4181-a6ef-45206f0621f72024-10-16Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDENuCare Pharmaceuticals, Inc.3f14442c-8178-0bad-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsName fallback
brand name: verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.a58f5f77-7e88-d622-e053-2a95a90a0d352024-07-17Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEAmneal Pharmaceuticals LLC9055ed6b-f466-4f38-a9d9-f22e9ac97ad42024-07-10Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEBryant Ranch Prepackf88dfe56-08bc-46b1-8f05-f886a16a89bc2024-07-08Warnings, 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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59923-605Verapamil HydrochlorideVerapamil HydrochlorideAreva PharmaceuticalsANDACurrent
59923-605Verapamil HydrochlorideVerapamil HydrochlorideAreva PharmaceuticalsANDACurrent
59923-605Verapamil HydrochlorideVerapamil HydrochlorideAreva PharmaceuticalsANDACurrent