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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A071483-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071483-002	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A071483-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A071483-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071483-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A071483-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071483-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A071483-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071483-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A071483-002	AB	1	`ea99ee380514…`

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 2 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	PD-Rx Pharmaceuticals, Inc.	3c215e6c-d85a-4102-a1c2-f00fa3169a55	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9d529fe3-7b5c-4dde-9a8c-440a969df359	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Northwind Health Company, LLC	f2f059a1-0cf9-a5d6-e053-2a95a90a3dab	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Northwind Health Company, LLC	db990ce1-b193-4a81-e053-2a95a90a627b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Northwind Health Company, LLC	adc77fea-db39-aac5-e053-2995a90ad458	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Northwind Health Company, LLC	e08c07bf-58b4-6fa2-e053-2a95a90aca32	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Northwind Health Company, LLC	62c3aadf-412e-41a5-9e57-2c48d962f90a	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Northwind Health Company, LLC	f7814f9a-e589-4041-e053-6294a90a29e3	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	ProPharma Distribution	386ae2d7-ddf7-a753-e063-6294a90ab45e	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Chartwell RX, LLC	ebc9a09a-7b5f-4df6-ace7-31185d469b28	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	ba1bf1ae-9347-4d17-998b-14bf7b5984ce	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Henry Schein, Inc.	262608c5-843a-4122-b858-5affdc670389	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Henry Schein, Inc.	9650680c-89ae-451b-aa75-4d34158866e7	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	REMEDYREPACK INC.	d7c29dfd-3968-41ac-a081-e670f9bd605c	2025-11-03	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Medical Purchasing Solutions, LLC.	424f538f-8785-8279-e063-6394a90aeb4c	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	af1249b0-e889-4f02-bdc2-54862de0545e	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	b0eeada4-1010-4c11-b408-29f9a1af23c0	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	c7a54ee0-80c0-4c7e-a6a3-cb60142f860c	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Teva Pharmaceuticals Inc	0742cf97-601b-4c13-a6c3-1a6a616ed292	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Mylan Institutional Inc.	3bee2d26-138c-4641-a217-a38d3d657461	2025-07-22	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