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 4 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	NuCare Pharmaceuticals,Inc.	7b321aa1-1b53-26d5-e053-2991aa0a1373	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Bryant Ranch Prepack	2f232216-db62-4dc6-a5a7-9139d7ac7589	2024-05-24	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Bryant Ranch Prepack	006cf920-04ae-0b53-cb91-85481972abc2	2024-05-22	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	HF Acquisition Co. LLC, DBA HealthFirst	74d94dbf-0567-6c15-e053-2991aa0ac6e4	2024-02-22	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	951c7fd7-10ef-2b07-e053-2995a90aaffd	2024-02-19	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Actavis Pharma, Inc.	a0343397-897b-46d6-943f-a87e07e1de10	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Bryant Ranch Prepack	d4a6c046-81fe-4b2a-9cb0-adb3f037eec7	2024-01-26	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Bryant Ranch Prepack	2f839b5c-b8e7-40df-887f-7df94326fc7b	2023-12-08	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Eugia US LLC	def3b9ba-523d-4b83-a80d-fa6f362e111c	2023-07-24	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	A-S Medication Solutions	5467dad4-f3ba-4036-b5f4-4d2d4d5abc34	2023-06-12	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6685248d-908e-cd07-e053-2a91aa0ac718	2023-05-30	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9e04440f-4cee-990b-e053-2995a90a09e1	2023-05-10	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9f19a5b4-286c-2c3f-e053-2a95a90a51df	2023-05-09	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	A-S Medication Solutions	f00c1caf-68b6-40c1-a1fa-72d17d2cf44f	2023-05-04	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	a2a4b816-417c-4a37-e053-2995a90a0220	2023-05-03	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Proficient Rx LP	343724eb-e80b-4729-80e7-6b8028713ea1	2023-05-01	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	bfc7fa37-1ee3-5eb2-e053-2995a90a5622	2023-04-27	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Sagent Pharmaceuticals	a76b2cff-7029-4607-88db-9921ec2842b6	2023-04-25	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	e99a1aea-cd0a-59cb-e053-2a95a90a1147	2023-04-24	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Zydus Lifesciences Limited	cccf4a5f-6c5d-4d52-97e4-fe7a2dbd28d8	2022-11-05		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