Application 021688

Type: NDA
Sponsor: AMGEN

Application Products#

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

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	RLD / RS	Approval date
N021688-001	SENSIPAR	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	RLD	2004-03-08
N021688-002	SENSIPAR	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	RLD	2004-03-08
N021688-003	SENSIPAR	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	RLD	2004-03-08

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02
N021688-001	9375405	2026-09-22		Drug product	2016-07-22
N021688-002	7829595	2026-09-22	U-1098	Drug product
N021688-002	9375405	2026-09-22		Drug product	2016-07-22
N021688-003	7829595	2026-09-22	U-1098	Drug product
N021688-003	9375405	2026-09-22		Drug product	2016-07-22

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 · 123 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
2026-02-19 14:30 UTC	2026-02	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL		RLD	2004-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL		RLD	2004-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL		RLD	2004-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL		RLD	2004-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL		RLD	2004-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL		RLD	2004-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL		RLD	2004-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL		RLD	2004-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL		RLD	2004-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL		RLD	2004-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL		RLD	2004-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL		RLD	2004-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL		RLD	2004-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL		RLD	2004-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL		RLD	2004-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL		RLD	2004-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL		RLD	2004-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL		RLD	2004-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL	AB	RLD, RS	2004-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL	AB	RLD, RS	2004-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL	AB	RLD, RS	2004-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL	AB	RLD, RS	2004-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL	AB	RLD, RS	2004-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL	AB	RLD, RS	2004-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL	AB	RLD, RS	2004-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021688-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021688-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021688-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021688-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021688-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021688-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021688-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021688-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021688-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021688-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021688-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021688-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021688-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021688-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021688-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021688-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021688-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021688-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021688-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021688-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021688-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021688-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021688-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021688-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021688-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021688-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021688-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021688-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021688-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021688-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021688-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021688-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021688-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021688-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021688-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021688-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021688-001	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021688-001	9375405	2026-09-22		Drug product	2016-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021688-002	7829595	2026-09-22	U-1098	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021688-002	9375405	2026-09-22		Drug product	2016-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021688-003	7829595	2026-09-22	U-1098	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021688-003	9375405	2026-09-22		Drug product	2016-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-001	9375405	2026-09-22		Drug product	2016-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-002	7829595	2026-09-22	U-1098	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-002	9375405	2026-09-22		Drug product	2016-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-003	7829595	2026-09-22	U-1098	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-003	9375405	2026-09-22		Drug product	2016-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021688-001	9375405	2026-09-22		Drug product	2016-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021688-002	7829595	2026-09-22	U-1098	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021688-002	9375405	2026-09-22		Drug product	2016-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021688-003	7829595	2026-09-22	U-1098	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021688-003	9375405	2026-09-22		Drug product	2016-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-001	9375405	2026-09-22		Drug product	2016-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-002	7829595	2026-09-22	U-1098	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-002	9375405	2026-09-22		Drug product	2016-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-003	7829595	2026-09-22	U-1098	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-003	9375405	2026-09-22		Drug product	2016-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-001	9375405	2026-09-22		Drug product	2016-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-002	7829595	2026-09-22	U-1098	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-002	9375405	2026-09-22		Drug product	2016-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-003	7829595	2026-09-22	U-1098	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-003	9375405	2026-09-22		Drug product	2016-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-001	9375405	2026-09-22		Drug product	2016-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-002	7829595	2026-09-22	U-1098	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-002	9375405	2026-09-22		Drug product	2016-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-003	7829595	2026-09-22	U-1098	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-003	9375405	2026-09-22		Drug product	2016-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-001	9375405	2026-09-22		Drug product	2016-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-002	7829595	2026-09-22	U-1098	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-002	9375405	2026-09-22		Drug product	2016-07-22	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021688-001	M-200	2020-05-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021688-001	ODE-78	2021-11-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021688-002	M-200	2020-05-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021688-002	ODE-78	2021-11-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021688-003	M-200	2020-05-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021688-003	ODE-78	2021-11-21	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021688-001	ODE-78	2021-11-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021688-002	ODE-78	2021-11-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021688-003	ODE-78	2021-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021688-001	ODE-78	2021-11-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021688-002	ODE-78	2021-11-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021688-003	ODE-78	2021-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021688-001	ODE-78	2021-11-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021688-002	ODE-78	2021-11-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021688-003	ODE-78	2021-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021688-001	M-200	2020-05-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021688-001	ODE-78	2021-11-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021688-002	M-200	2020-05-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021688-002	ODE-78	2021-11-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021688-003	M-200	2020-05-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021688-003	ODE-78	2021-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021688-001	M-200	2020-05-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021688-001	ODE-78	2021-11-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021688-002	M-200	2020-05-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021688-002	ODE-78	2021-11-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021688-003	M-200	2020-05-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021688-003	ODE-78	2021-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021688-001	M-200	2020-05-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021688-001	ODE-78	2021-11-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021688-002	M-200	2020-05-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021688-002	ODE-78	2021-11-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021688-003	M-200	2020-05-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021688-003	ODE-78	2021-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021688-001	M-200	2020-05-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021688-001	ODE-78	2021-11-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021688-002	M-200	2020-05-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021688-002	ODE-78	2021-11-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021688-003	M-200	2020-05-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021688-003	ODE-78	2021-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021688-001	M-200	2020-05-23	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sensipar	CINACALCET HYDROCHLORIDE	Amgen Inc	45028573-13c4-4c8b-ae62-6c75bba97c81	2025-12-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021688 application number: NDA021688 ndc (product): 55513-073 ndc (product): 55513-075 ndc (product): 55513-074

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3529	Sensipar	cinacalcet hydrochloride	A-S Medication Solutions	NDA	Current
50090-3529	Sensipar	cinacalcet hydrochloride	A-S Medication Solutions	NDA	Current
50090-4470	Sensipar	cinacalcet hydrochloride	A-S Medication Solutions	NDA	Current
53808-0577	Sensipar	cinacalcet hydrochloride	State of Florida DOH Central Pharmacy	NDA	Current
53808-0578	Sensipar	cinacalcet hydrochloride	State of Florida DOH Central Pharmacy	NDA	Current
55513-073	Sensipar	cinacalcet hydrochloride	Amgen Inc	NDA	Current
55513-073	Sensipar	cinacalcet hydrochloride	Amgen Inc	NDA	Current
55513-073	Sensipar	cinacalcet hydrochloride	Amgen Inc	NDA	Current
55513-073	Sensipar	cinacalcet hydrochloride	Amgen Inc	NDA	Current
55513-074	Sensipar	cinacalcet hydrochloride	Amgen Inc	NDA	Current
55513-074	Sensipar	cinacalcet hydrochloride	Amgen Inc	NDA	Current
55513-074	Sensipar	cinacalcet hydrochloride	Amgen Inc	NDA	Current
55513-074	Sensipar	cinacalcet hydrochloride	Amgen Inc	NDA	Current
55513-075	Sensipar	cinacalcet hydrochloride	Amgen Inc	NDA	Current
55513-075	Sensipar	cinacalcet hydrochloride	Amgen Inc	NDA	Current
55513-075	Sensipar	cinacalcet hydrochloride	Amgen Inc	NDA	Current
55513-075	Sensipar	cinacalcet hydrochloride	Amgen Inc	NDA	Current
68151-4740	Sensipar	cinacalcet hydrochloride	Carilion Materials Management	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61219	SUPPL	2019-12-10
61170	SUPPL	2019-12-06
58207	SUPPL	2019-04-04
58206	SUPPL	2019-04-04
58166	SUPPL	2019-04-01
58165	SUPPL	2019-04-01
48540	SUPPL	2017-05-25
48529	SUPPL	2017-05-25
48400	SUPPL	2017-05-17
48389	SUPPL	2017-05-17
37458	SUPPL	2014-11-25
37457	SUPPL	2014-11-25
15985	SUPPL	2014-11-25
28376	SUPPL	2014-11-24
5986	SUPPL	2014-11-24
5985	SUPPL	2014-11-24
37456	SUPPL	2011-08-12
5984	SUPPL	2011-08-03
37455	SUPPL	2011-03-04
5983	SUPPL	2011-03-02
28375	SUPPL	2010-01-21
37454	SUPPL	2009-11-16
37453	SUPPL	2009-01-06
28374	SUPPL	2008-12-29
5982	SUPPL	2008-05-07
15984	SUPPL	2008-03-05
5981	SUPPL	2008-03-04
37452	SUPPL	2007-10-10
28373	SUPPL	2007-10-10
21779	ORIG	2004-05-10
15983	ORIG	2004-04-05
5980	ORIG	2004-03-10
52569	SUPPL	1900-01-01
52568	SUPPL	1900-01-01
52567	SUPPL	1900-01-01
52566	SUPPL	1900-01-01