Application 209226

Type: ANDA
Sponsor: STRIDES PHARMA

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	RLD / RS	Approval date
A209226-001	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30
A209226-002	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30
A209226-003	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	RS	2018-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209226-001	AB
A209226-002	AB
A209226-003	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	RS	2018-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	RS	2018-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	RS	2018-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	RS	2018-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	RS	2018-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	RS	2018-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	RS	2018-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB		2018-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB		2018-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB		2018-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB		2018-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB		2018-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB		2018-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`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	A209226-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209226-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209226-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209226-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209226-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209226-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209226-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209226-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209226-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209226-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209226-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209226-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209226-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209226-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209226-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209226-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209226-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209226-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209226-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209226-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209226-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209226-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209226-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209226-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209226-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209226-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209226-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209226-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209226-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209226-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209226-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209226-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209226-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209226-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209226-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209226-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209226-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209226-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209226-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209226-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cinacalcet	CINACALCET	REMEDYREPACK INC.	1c78bfff-7a82-4d1d-bc61-718c3ff3aa92	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209226 application number: ANDA209226
Cinacalcet	CINACALCET	AvPAK	4d2f2a92-ee1c-084a-e063-6294a90aae96	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209226 application number: ANDA209226
Cinacalcet	CINACALCET	Major Pharmaceuticals	0692252e-4cc6-4f16-8a54-aeacd59c3143	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209226 application number: ANDA209226
Cinacalcet	CINACALCET	Strides Pharma Science Limited	0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d7	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209226 application number: ANDA209226 ndc (product): 64380-884 ndc (product): 64380-885 ndc (product): 64380-883
Cinacalcet	CINACALCET	American Health Packaging	44b548ef-1679-4d15-86ad-0d9636b48a45	2025-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209226 application number: ANDA209226

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42543-961	Cinacalcet	Cinacalcet	Strides Pharma Inc.	ANDA	Current
42543-962	Cinacalcet	Cinacalcet	Strides Pharma Inc.	ANDA	Current
42543-963	Cinacalcet	Cinacalcet	Strides Pharma Inc.	ANDA	Current
51407-295	Cinacalcet	Cinacalcet	Golden State Medical Supply	ANDA	Current
51407-295	Cinacalcet	Cinacalcet	Golden State Medical Supply	ANDA	Current
51407-295	Cinacalcet	Cinacalcet	Golden State Medical Supply	ANDA	Current
51407-296	Cinacalcet	Cinacalcet	Golden State Medical Supply	ANDA	Current
51407-296	Cinacalcet	Cinacalcet	Golden State Medical Supply	ANDA	Current
51407-296	Cinacalcet	Cinacalcet	Golden State Medical Supply	ANDA	Current
51407-297	Cinacalcet	Cinacalcet	Golden State Medical Supply	ANDA	Current
51407-297	Cinacalcet	Cinacalcet	Golden State Medical Supply	ANDA	Current
51407-297	Cinacalcet	Cinacalcet	Golden State Medical Supply	ANDA	Current
64380-883	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-883	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-883	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-883	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-883	Cinacalcet	Cinacalcet	Strides Pharma Science Limited	ANDA	Current
64380-883	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-883	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-884	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-884	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-884	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-884	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-884	Cinacalcet	Cinacalcet	Strides Pharma Science Limited	ANDA	Current
64380-884	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-884	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-885	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-885	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-885	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-885	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-885	Cinacalcet	Cinacalcet	Strides Pharma Science Limited	ANDA	Current
64380-885	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-885	Cinacalcet Hydrochloride	Cinacalcet Hydrochloride	Strides Pharma Science Limited	ANDA	Current