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 1.

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
2026-02-19 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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	861247cc-3edf-4497-b230-2147489548b3	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218638 application number: ANDA218638

Documents#

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