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 42.

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
2026-08-18 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 1 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	Micro Labs Limited	8e8611e0-7d8c-4f30-b53a-76c6588b6ef7	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: NICARDIPINE HYDROCHLORIDE generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	Amerisyn LLC	575c5dab-e832-192a-e063-6294a90a34a1	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: NICARDIPINE HYDROCHLORIDE generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Caplin Steriles Limited	9383f1dc-0310-4c87-a8f0-48c09a85d89b	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine hydrochloride	NICARDIPINE HYDROCHLORIDE	Lifestar Pharma LLC	b0e2bed3-f928-43ab-a05c-275bedc9856f	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Nicardipine hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Somerset Therapeutics, LLC	f8b49f59-7a54-425d-9eca-dfa4022a08d1	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
CARDENE IV	NICARDIPINE HYDROCHLORIDE	Baxter Healthcare Corporation	a3e33add-0d09-423a-9109-42e5ba7148d5	2026-04-13	Warnings, Adverse reactions	Name fallback generic name: NICARDIPINE HYDROCHLORIDE
Cardene IV	NICARDIPINE HYDROCHLORIDE	Baxter Healthcare Corporation	5499cfac-9147-4d5d-a8cb-f8d64f1481af	2026-04-13	Warnings, Adverse reactions	Name fallback generic name: NICARDIPINE HYDROCHLORIDE
CARDENE IV	NICARDIPINE HYDROCHLORIDE	Baxter Healthcare Corporation	f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e	2026-03-27	Warnings, Adverse reactions	Name fallback generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	cdafe6cc-b03e-4e72-9d0a-6baa977149d6	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: NICARDIPINE HYDROCHLORIDE generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	3955d43d-a87f-4d2c-b90e-3ecf0d6aa148	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	Amici Pharma Inc	edda985c-004e-4487-b856-13cf2cdb900f	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: NICARDIPINE HYDROCHLORIDE generic name: NICARDIPINE HYDROCHLORIDE
CARDENE IV	NICARDIPINE HYDROCHLORIDE	Baxter Healthcare Corporation	5749599d-ff2a-42e4-aa72-cd25013feee8	2025-12-29	Warnings, Adverse reactions	Name fallback generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Sagent Pharmaceuticals	c576c9d5-853b-4e93-be6c-3579dfa5564c	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	d1e275b8-c71a-4e8b-bca0-cfea048b5343	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	Chengdu Shuode Pharmaceutical Co., Ltd	433dbca3-0a86-44c2-835d-1051c1c93878	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: NICARDIPINE HYDROCHLORIDE generic name: NICARDIPINE HYDROCHLORIDE
nicardipine hydrochloride	NICARDIPINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	372a4381-7302-4df7-81bb-a9521907f867	2025-08-28	Warnings, Adverse reactions	Name fallback brand name: nicardipine hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride in Sodium Chloride	NICARDIPINE HYDROCHLORIDE	WG Critical Care, LLC	9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d	2025-06-30	Warnings, Adverse reactions	Name fallback generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	7433b5cd-9c3a-428a-bcaf-00f02cd52633	2025-04-23	Warnings, Adverse reactions	Name fallback brand name: Nicardipine Hydrochloride generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	Cipla USA Inc.	570af1f8-6718-4b40-ae89-0f738d330ebd	2025-04-08	Warnings, Adverse reactions	Name fallback brand name: NICARDIPINE HYDROCHLORIDE generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9d898911-d811-2a78-e053-2995a90af784	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: NICARDIPINE HYDROCHLORIDE generic name: NICARDIPINE HYDROCHLORIDE

Documents#

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