Application 070995

Type
ANDA
Sponsor
WATSON LABS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A070995-001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070995-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-013f01610625f2…
2019-09-15 20:21 UTC2019-09A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070995-001VERAPAMIL HYDROCHLORIDE80MGTABLET / ORALAB1986-10-01cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A070995-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070995-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070995-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070995-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070995-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070995-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070995-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070995-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070995-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070995-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070995-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070995-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070995-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070995-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070995-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070995-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070995-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070995-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070995-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070995-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070995-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070995-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070995-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070995-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070995-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070995-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070995-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070995-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070995-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070995-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070995-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070995-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070995-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070995-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070995-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070995-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070995-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070995-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070995-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070995-001AB1cb3db0bc1861…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEActavis Pharma, Inc.a0343397-897b-46d6-943f-a87e07e1de102024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070995
application number: ANDA070995
ndc (product): 0591-0343

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-0343Verapamil HydrochlorideVerapamil HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-0343Verapamil HydrochlorideVerapamil HydrochlorideActavis Pharma, Inc.ANDACurrent
0615-7618Verapamil HydrochlorideVerapamil HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-2920Verapamil HydrochlorideVerapamil HydrochlorideMajor PharmaceuticalsANDACurrent
0904-2920Verapamil HydrochlorideVerapamil HydrochlorideMajor PharmaceuticalsANDACurrent
0904-2920Verapamil HydrochlorideVerapamil HydrochlorideMajor PharmaceuticalsANDACurrent
70518-0785Verapamil HydrochlorideVerapamil HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0785Verapamil HydrochlorideVerapamil HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1852Verapamil HydrochlorideVerapamil HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2289Verapamil HydrochlorideVerapamil HydrochlorideREMEDYREPACK INC.ANDACurrent