Application 090529

Type
ANDA
Sponsor
SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL120MGNoNo
002VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL180MGNoNo
003VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL240MGNoNo

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

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
A090529-001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2011-12-30
A090529-002VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORAL2011-12-30
A090529-003VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORAL2011-12-30

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090529-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2011-12-3084e616aacf4f…
2026-09-14 22:38:342026-08A090529-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORAL2011-12-3084e616aacf4f…
2026-09-14 22:38:342026-08A090529-003VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORAL2011-12-3084e616aacf4f…
2026-08-18 06:07:402026-07A090529-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2011-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07A090529-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORAL2011-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07A090529-003VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORAL2011-12-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090529-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2011-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090529-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORAL2011-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090529-003VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORAL2011-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090529-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2011-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090529-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORAL2011-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090529-003VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORAL2011-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090529-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2011-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090529-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORAL2011-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090529-003VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORAL2011-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090529-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2011-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090529-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORAL2011-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090529-003VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORAL2011-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090529-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2011-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090529-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORAL2011-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090529-003VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORAL2011-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090529-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2011-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090529-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORAL2011-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090529-003VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORAL2011-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090529-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2011-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090529-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORAL2011-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090529-003VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORAL2011-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090529-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2011-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090529-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORAL2011-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090529-003VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORAL2011-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090529-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2011-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090529-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORAL2011-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090529-003VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORAL2011-12-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090529-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2011-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A090529-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORAL2011-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A090529-003VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORAL2011-12-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090529-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2011-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090529-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORAL2011-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090529-003VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORAL2011-12-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090529-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2011-12-30301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090529-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090529-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090529-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090529-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090529-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090529-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090529-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090529-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090529-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090529-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090529-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090529-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090529-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090529-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090529-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090529-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090529-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090529-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090529-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090529-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090529-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090529-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090529-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090529-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090529-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090529-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090529-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090529-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090529-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090529-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090529-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090529-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090529-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090529-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090529-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090529-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090529-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090529-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090529-003AB1ea99ee380514…
2023-12-20 04:57 UTC2023-12A090529-001AB1ea1830bbd6c7…

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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-561VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-561VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-561VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-562VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-562VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-992VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
53808-1019VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
55700-650VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-650VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
57664-116VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
57664-116VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
57664-117VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
57664-117VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
57664-118VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
57664-118VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
68071-4663VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4663VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
68788-0625VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ANDACurrent
71335-0928VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0928VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEBryant Ranch PrepackANDACurrent