Application 210570

Type: ANDA
Sponsor: ALKEM LABS LTD

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 42.

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	TE codes	Approval date
A210570-001	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2019-05-17
A210570-002	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2019-05-17
A210570-003	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2019-05-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A210570-001	AB
A210570-002	AB
A210570-003	AB

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 · 126 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
2026-08-18 06:07:40	2026-07	A210570-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2019-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210570-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2019-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210570-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2019-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210570-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2019-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210570-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2019-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210570-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2019-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210570-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2019-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210570-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2019-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210570-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2019-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210570-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2019-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210570-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2019-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210570-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2019-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210570-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2019-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210570-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2019-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210570-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2019-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210570-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2019-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210570-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2019-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210570-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2019-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210570-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2019-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210570-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2019-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210570-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2019-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210570-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2019-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210570-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2019-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210570-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2019-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210570-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2019-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210570-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2019-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210570-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2019-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210570-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2019-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210570-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2019-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210570-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2019-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210570-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2019-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210570-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2019-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210570-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2019-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210570-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2019-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210570-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2019-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210570-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2019-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210570-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2019-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210570-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2019-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210570-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2019-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210570-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2019-05-17	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210570-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210570-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210570-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210570-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210570-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210570-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210570-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210570-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210570-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210570-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210570-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210570-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210570-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210570-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210570-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210570-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210570-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210570-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210570-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210570-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210570-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210570-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210570-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210570-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210570-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210570-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210570-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210570-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210570-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210570-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210570-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210570-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210570-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210570-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210570-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210570-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210570-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210570-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210570-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210570-001	AB	1	`1e350fbaab3a…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cinacalcet	CINACALCET	Bryant Ranch Prepack	79b64bbb-3682-4b31-9bb6-03e2c5ac5a2c	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210570 application number: ANDA210570
Cinacalcet	CINACALCET	Bryant Ranch Prepack	330b4214-dba7-468c-a67e-b1057f4628da	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210570 application number: ANDA210570
Cinacalcet	CINACALCET	Bryant Ranch Prepack	f1cfc943-5b70-4451-a1fc-61e45e669d84	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210570 application number: ANDA210570
Cinacalcet	CINACALCET	Bryant Ranch Prepack	60e6264c-723c-49b2-a246-827b15ff219c	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210570 application number: ANDA210570 ndc (product): 63629-9608
Cinacalcet	CINACALCET	Bryant Ranch Prepack	b920a91f-309f-4f83-a123-525b3bdd55b7	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210570 application number: ANDA210570 ndc (product): 63629-9606
Cinacalcet	CINACALCET	Bryant Ranch Prepack	e96cfada-3763-4af7-b323-1256926a797c	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210570 application number: ANDA210570 ndc (product): 63629-9607
Cinacalcet	CINACALCET	Bryant Ranch Prepack	86fe67f9-d4e0-4966-a80b-c04bf6bb0ef9	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210570 application number: ANDA210570 ndc (product): 63629-8763
Cinacalcet	CINACALCET	Bryant Ranch Prepack	c288922b-3258-4c1c-bd8a-32a41dd43a63	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210570 application number: ANDA210570 ndc (product): 63629-8764
Cinacalcet	CINACALCET	Ascend Laboratories, LLC	55f95ae0-84ac-4ae4-b7a0-7590ab919ae1	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210570 application number: ANDA210570 ndc (product): 67877-503 ndc (product): 67877-505 ndc (product): 67877-504

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7067	Cinacalcet	Cinacalcet	Major Pharmaceuticals	ANDA	Current
0904-7067	Cinacalcet	Cinacalcet	Major Pharmaceuticals	ANDA	Current
60687-525	Cinacalcet	Cinacalcet	American Health Packaging	ANDA	Current
60687-525	Cinacalcet	Cinacalcet	American Health Packaging	ANDA	Current
60687-525	Cinacalcet	Cinacalcet	American Health Packaging	ANDA	Current
63629-8763	Cinacalcet	Cinacalcet	Bryant Ranch Prepack	ANDA	Current
63629-8763	Cinacalcet	Cinacalcet	Bryant Ranch Prepack	ANDA	Current
63629-8763	Cinacalcet	Cinacalcet	Bryant Ranch Prepack	ANDA	Current
63629-8764	Cinacalcet	Cinacalcet	Bryant Ranch Prepack	ANDA	Current
63629-8764	Cinacalcet	Cinacalcet	Bryant Ranch Prepack	ANDA	Current
63629-8764	Cinacalcet	Cinacalcet	Bryant Ranch Prepack	ANDA	Current
63629-8765	Cinacalcet	Cinacalcet	Bryant Ranch Prepack	ANDA	Current
63629-8765	Cinacalcet	Cinacalcet	Bryant Ranch Prepack	ANDA	Current
63629-8765	Cinacalcet	Cinacalcet	Bryant Ranch Prepack	ANDA	Current
63629-9606	Cinacalcet	Cinacalcet	Bryant Ranch Prepack	ANDA	Current
63629-9607	Cinacalcet	Cinacalcet	Bryant Ranch Prepack	ANDA	Current
63629-9608	Cinacalcet	Cinacalcet	Bryant Ranch Prepack	ANDA	Current
67877-503	Cinacalcet	Cinacalcet	Ascend Laboratories, LLC	ANDA	Current
67877-503	Cinacalcet	Cinacalcet	Ascend Laboratories, LLC	ANDA	Current
67877-503	Cinacalcet	Cinacalcet	Ascend Laboratories, LLC	ANDA	Current
67877-503	Cinacalcet	Cinacalcet	Ascend Laboratories, LLC	ANDA	Current
67877-504	Cinacalcet	Cinacalcet	Ascend Laboratories, LLC	ANDA	Current
67877-504	Cinacalcet	Cinacalcet	Ascend Laboratories, LLC	ANDA	Current
67877-504	Cinacalcet	Cinacalcet	Ascend Laboratories, LLC	ANDA	Current
67877-504	Cinacalcet	Cinacalcet	Ascend Laboratories, LLC	ANDA	Current
67877-505	Cinacalcet	Cinacalcet	Ascend Laboratories, LLC	ANDA	Current
67877-505	Cinacalcet	Cinacalcet	Ascend Laboratories, LLC	ANDA	Current
67877-505	Cinacalcet	Cinacalcet	Ascend Laboratories, LLC	ANDA	Current
67877-505	Cinacalcet	Cinacalcet	Ascend Laboratories, LLC	ANDA	Current