Application 218638

Type: ANDA
Sponsor: NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	CAPSULE;ORAL	20MG	No	No
002	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	CAPSULE;ORAL	30MG	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
A218638-001	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			2025-06-25
A218638-002	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			2025-06-25

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.

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	A218638-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL		2025-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218638-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2025-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218638-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL		2025-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218638-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2025-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218638-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2025-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218638-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2025-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218638-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2025-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218638-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2025-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218638-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2025-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218638-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2025-06-25	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218638-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL		2025-06-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218638-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2025-06-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218638-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218638-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218638-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218638-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218638-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218638-002	AB	1	`6a471c1ec25d…`

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Archis Pharma LLC	d0070638-bea5-413a-8658-4c752c6104f5	2024-12-05	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Bionpharma Inc.	7bed5d8c-30c2-4598-acf3-2edba825a56d	2024-11-04	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine hydrochloride	NICARDIPINE	Amneal Pharmaceuticals NY LLC	79304b0f-53d3-4065-8c81-7031d1141694	2024-10-03	Warnings, Adverse reactions	Name fallback brand name: Nicardipine hydrochloride
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	18fb1c2b-0c1e-436c-a5b6-d4840b5da228	2024-08-24	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Armas Pharmaceuticals Inc.	7226a518-164b-4755-9624-1cc75c939063	2024-04-04	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Epic Pharma, LLC	b8f147b8-955f-4733-9178-2cfa0beb60d6	2023-12-27	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	Burel Pharmaceuticals, LLC	cb902af0-b5ad-4680-b2f2-007ef2196efe	2023-09-07	Warnings, Adverse reactions	Name fallback brand name: NICARDIPINE HYDROCHLORIDE generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	Eugia US LLC	9f5d3050-9cdf-404f-ac0f-72399178959f	2023-06-23	Warnings, Adverse reactions	Name fallback brand name: NICARDIPINE HYDROCHLORIDE generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	Eugia US LLC	dcd7d173-4d8e-4282-9edf-817711340e43	2021-10-11	Warnings, Adverse reactions	Name fallback brand name: NICARDIPINE HYDROCHLORIDE generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	55bd6dcc-1f12-4378-8e9e-1ceed26818f5	2021-07-21	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	American Regent, Inc.	76fcb7e0-9034-4fcd-be14-ce7e9ccaee2a	2020-05-01	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Civica, Inc.	30fb3a4d-fa75-42fd-b4b6-2a21f202027f	2020-05-01	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	PuraCap Laboratories LLC dba Blu Pharmaceuticals	065efabf-8c7d-4dd5-aef2-700c2eca399d	2019-01-07	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	West-Ward Pharmaceuticals Corp	0eb7d839-63d9-4b51-bf7b-4a8fde6339b5	2018-12-12	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82698	ORIG	2025-06-30