Home Applications 071483 Application 071483
Type ANDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET;ORAL 120MG No No 002 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET;ORAL 80MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071483-001 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 A071483-002 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15
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 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL 1989-02-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL 1989-02-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071483-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET / ORAL AB 1989-02-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A071483-002 VERAPAMIL HYDROCHLORIDE 80MG TABLET / ORAL AB 1989-02-15 74a2ff9319b5…
Observed Orange Book normalized TE history# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ed1e0c14-3571-43f9-88fc-5a4d2b598263 2022-03-12 Warnings, Adverse reactions Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE Mylan Pharmaceuticals Inc. c86084bc-33aa-eece-5a96-6c0dad2d1a32 2021-06-21 Warnings, Adverse reactions Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE Verapamil hydrochloride VERAPAMIL HYDROCHLORIDE Gland Pharma Limited eb3c66f6-581f-422b-9ca2-9b877b323a33 2020-10-19 Warnings, Adverse reactions Name fallback brand name: Verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 2712ab16-122b-4f44-a687-e2cb3c04019e 2020-04-09 Warnings, Adverse reactions Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE Baxter Healthcare Corporation 03c5daf8-5399-4d89-a747-9a9d7667b6e4 2020-03-25 Warnings, Adverse reactions Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE Armas Pharmaceuticals Inc. 2d595d9d-af88-474d-b622-d63d786f06a7 2020-01-08 Warnings, Adverse reactions Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE Armas Pharmaceuticals Inc. 51597adb-bfb1-4611-b577-8989724fc3a4 2020-01-04 Warnings, Adverse reactions Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE verapamil hydrochloride VERAPAMIL HYDROCHLORIDE Proficient Rx LP 19cb23bd-cc6d-45fc-a1fc-b4130ea460a6 2019-11-01 Warnings, Adverse reactions Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE Proficient Rx LP a6de732a-fe48-486d-bb05-0a9fff6f42d7 2019-10-01 Warnings, Adverse reactions Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE verapamil hydrochloride VERAPAMIL HYDROCHLORIDE Proficient Rx LP 4ffa579e-1d85-4b3b-ae06-6a9334e0f9e1 2019-10-01 Warnings, Adverse reactions Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE verapamil hydrochloride VERAPAMIL HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC c635f442-2349-4820-877a-a42e5f0a44b5 2019-05-08 Warnings, Adverse reactions Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE EXELA PHARMA SCIENCES, LLC eff5e83b-f819-4a5b-9746-12bce328d7a7 2017-02-21 Warnings, Adverse reactions Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE EXELA PHARMA SCIENCES, LLC 3318e357-0660-44f4-8170-91a51bd762fb 2017-01-23 Warnings, Adverse reactions Name 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-0512 Verapamil Hydrochloride verapamil hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 0378-0512 Verapamil Hydrochloride verapamil hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 0378-0772 Verapamil Hydrochloride verapamil hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 0378-0772 Verapamil Hydrochloride verapamil hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 55289-481 Verapamil Hydrochloride verapamil hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current