Application 209403

Type: ANDA
Sponsor: HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	TABLET;ORAL	EQ 30MG BASE	No	No
002	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	TABLET;ORAL	EQ 60MG BASE	No	No
003	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	TABLET;ORAL	EQ 90MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A209403-001	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2020-10-07
A209403-002	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	2020-10-07
A209403-003	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	2020-10-07

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 · 111 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
2026-02-19 14:30 UTC	2026-02	A209403-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2020-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209403-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2020-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209403-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2020-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209403-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2020-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209403-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2020-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209403-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2020-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209403-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2020-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209403-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2020-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209403-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2020-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209403-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2020-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209403-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2020-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209403-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2020-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209403-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2020-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209403-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2020-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209403-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2020-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209403-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2020-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209403-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2020-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209403-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2020-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209403-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2020-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209403-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2020-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209403-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2020-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209403-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2020-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209403-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2020-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209403-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2020-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209403-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2020-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209403-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2020-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209403-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2020-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209403-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2020-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209403-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2020-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209403-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2020-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209403-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2020-10-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209403-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2020-10-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209403-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2020-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209403-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2020-10-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209403-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2020-10-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209403-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2020-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209403-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2020-10-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209403-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2020-10-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209403-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2020-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209403-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2020-10-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209403-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209403-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209403-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209403-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209403-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209403-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209403-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209403-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209403-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209403-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209403-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209403-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209403-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209403-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209403-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209403-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209403-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209403-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209403-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209403-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209403-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209403-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209403-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209403-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209403-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209403-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209403-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209403-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209403-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209403-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209403-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209403-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209403-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209403-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209403-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209403-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209403-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209403-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209403-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209403-001	AB	1	`8072bd15b7f6…`

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cinacalcet	CINACALCET	XLCare Pharmaceuticals Inc.	ff0b9500-085a-4e1e-a2e4-fd918ed70b2e	2023-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209403 application number: ANDA209403 ndc (product): 72865-152 ndc (product): 72865-151 ndc (product): 72865-150
Cinacalcet	CINACALCET	Camber Pharmaceuticals, Inc.	5480ebd3-5b39-4f8b-bb03-05617f6f519f	2020-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209403 application number: ANDA209403 ndc (product): 31722-103 ndc (product): 31722-105 ndc (product): 31722-104

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-103	Cinacalcet	Cinacalcet	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-104	Cinacalcet	Cinacalcet	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-105	Cinacalcet	Cinacalcet	Camber Pharmaceuticals, Inc.	ANDA	Current
72865-150	Cinacalcet	Cinacalcet	XLCare Pharmaceuticals Inc.	ANDA	Current
72865-151	Cinacalcet	Cinacalcet	XLCare Pharmaceuticals Inc.	ANDA	Current
72865-152	Cinacalcet	Cinacalcet	XLCare Pharmaceuticals Inc.	ANDA	Current