Application 019152

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALAN SR	VERAPAMIL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	240MG	Yes	Yes
002	CALAN SR	VERAPAMIL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	180MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	CALAN SR	VERAPAMIL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	120MG	Yes	Yes

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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019152-001	CALAN SR	VERAPAMIL HYDROCHLORIDE	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-12-16
N019152-002	CALAN SR	VERAPAMIL HYDROCHLORIDE	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1989-12-15
N019152-003	CALAN SR	VERAPAMIL HYDROCHLORIDE	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-03-06

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019152-001	CALAN SR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019152-002	CALAN SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1989-12-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019152-003	CALAN SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-03-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019152-001	CALAN SR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019152-002	CALAN SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1989-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019152-003	CALAN SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-03-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019152-001	CALAN SR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019152-002	CALAN SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1989-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019152-003	CALAN SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-03-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019152-001	CALAN SR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019152-002	CALAN SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1989-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019152-003	CALAN SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-03-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019152-001	CALAN SR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019152-002	CALAN SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1989-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019152-003	CALAN SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-03-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019152-001	CALAN SR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019152-002	CALAN SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1989-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019152-003	CALAN SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-03-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019152-001	CALAN SR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019152-002	CALAN SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1989-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019152-003	CALAN SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-03-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019152-001	CALAN SR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019152-002	CALAN SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1989-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019152-003	CALAN SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-03-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019152-001	CALAN SR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019152-002	CALAN SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1989-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019152-003	CALAN SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-03-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019152-001	CALAN SR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019152-002	CALAN SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1989-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019152-003	CALAN SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-03-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019152-001	CALAN SR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019152-002	CALAN SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1989-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019152-003	CALAN SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-03-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019152-001	CALAN SR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019152-002	CALAN SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1989-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019152-003	CALAN SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-03-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019152-001	CALAN SR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019152-002	CALAN SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1989-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019152-003	CALAN SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-03-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019152-001	CALAN SR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-12-16	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019152-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019152-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019152-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019152-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019152-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019152-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019152-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019152-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019152-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019152-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019152-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019152-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019152-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019152-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019152-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019152-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019152-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019152-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019152-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019152-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019152-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019152-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019152-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019152-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019152-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019152-003	AB	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N019152-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N019152-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019152-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019152-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019152-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N019152-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019152-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N019152-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019152-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019152-003	AB	1	`cb3db0bc1861…`

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 3 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	Golden State Medical Supply, Inc.	3283bba6-05dd-3766-e063-6394a90ada69	2025-04-11	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Chartwell RX, LLC	18f6d349-8c5c-4443-ac65-16bf6619ecdc	2025-03-25	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fe0583bf-9986-e01e-e053-6294a90a0b26	2025-02-04	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fe05b8d8-fdee-903b-e053-6394a90a2e05	2025-02-04	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	febce7aa-7f5a-e0c1-e053-6394a90aebc4	2025-02-04	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Caplin Steriles Limited	e18cc04c-a808-4d92-9b66-762cd787abc5	2025-01-16	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	d23c757d-39f8-48c3-ba63-df2cbe58c516	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
Verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	1076a3ef-de02-487f-8117-b4e80495db29	2024-12-26	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fdb7cd57-d33c-f5a3-e053-6294a90aff31	2024-12-13	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	a9a1a522-231b-41a1-95c6-0c75dbb62f47	2024-12-06	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	c87c7f7e-cdf5-42c7-a831-a7515d2d51d6	2024-12-06	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Wilshire Pharmaceuticals, Inc.	5f665d08-e1e4-422a-88c2-d8834abf9e1a	2024-11-27	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Wilshire Pharmaceuticals, Inc.	f9399858-fd7a-4b73-8759-3e5bf3af2666	2024-11-27	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	FRESENIUS KABI USA, LLC	38ca9270-5538-467a-a3e9-c27968f3aafe	2024-11-08	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Bryant Ranch Prepack	660a83a9-60be-42d5-bc70-fe384e93beaa	2024-10-24	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	A-S Medication Solutions	0b00ec93-0bb3-4181-a6ef-45206f0621f7	2024-10-16	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3f14442c-8178-0bad-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a58f5f77-7e88-d622-e053-2a95a90a0d35	2024-07-17	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	9055ed6b-f466-4f38-a9d9-f22e9ac97ad4	2024-07-10	Warnings, Adverse reactions	Name fallback generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Bryant Ranch Prepack	f88dfe56-08bc-46b1-8f05-f886a16a89bc	2024-07-08	Warnings, Adverse reactions	Name fallback 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 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0025-1891	CALAN SR	verapamil hydrochloride	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1891	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1891	CALAN SR	verapamil hydrochloride	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1891	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1891	CALAN SR	verapamil hydrochloride	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1891	CALAN SR	verapamil hydrochloride	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1891	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1891	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1891	CALAN SR	verapamil hydrochloride	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1891	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1891	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1901	CALAN SR	verapamil hydrochloride	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1901	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1901	CALAN SR	verapamil hydrochloride	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1901	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1901	CALAN SR	verapamil hydrochloride	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1901	CALAN SR	verapamil hydrochloride	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1901	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1901	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1901	CALAN SR	verapamil hydrochloride	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1901	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1901	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1911	CALAN SR	verapamil hydrochloride	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1911	CALAN SR	verapamil hydrochloride	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1911	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1911	CALAN SR	verapamil hydrochloride	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1911	CALAN SR	verapamil hydrochloride	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1911	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1911	CALAN SR	verapamil hydrochloride	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-2712	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2712	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2712	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2818	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2818	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2818	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2818	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2818	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2818	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2818	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2924	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2924	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2924	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2924	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2924	CALAN SR	verapamil hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
53808-0324	Verapamil Hydrochloride	Verapamil Hydrochloride	State of Florida DOH Central Pharmacy	NDA	Current
53808-0972	Verapamil Hydrochloride	Verapamil Hydrochloride	State of Florida DOH Central Pharmacy	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66995	SUPPL	2021-04-07
66818	SUPPL	2021-03-19
60705	SUPPL	2019-10-29
60704	SUPPL	2019-10-29
49798	SUPPL	2017-09-19
49761	SUPPL	2017-09-18
47293	SUPPL	2017-02-23
45233	SUPPL	2016-08-24
16205	SUPPL	2013-10-28
11441	SUPPL	2013-10-28
16204	SUPPL	2011-12-05
11440	SUPPL	2011-12-02
11439	SUPPL	2010-04-04
1238	SUPPL	2010-04-02
11438	SUPPL	2009-07-09
1237	SUPPL	2009-07-08
16203	SUPPL	2002-11-26