Application 208325

Type: NDA
Sponsor: KAI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PARSABIV	ETELCALCETIDE	SOLUTION;INTRAVENOUS	2.5MG/0.5ML (2.5MG/0.5ML)	Yes	Yes
002	PARSABIV	ETELCALCETIDE	SOLUTION;INTRAVENOUS	5MG/ML (5MG/ML)	Yes	Yes
003	PARSABIV	ETELCALCETIDE	SOLUTION;INTRAVENOUS	10MG/2ML (5MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N208325-001	PARSABIV	ETELCALCETIDE	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07
N208325-002	PARSABIV	ETELCALCETIDE	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07
N208325-003	PARSABIV	ETELCALCETIDE	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208325-001	8377880	2030-07-29		Drug substance, Drug product	2017-06-01
N208325-001	9278995	2030-07-29		Drug substance	2017-06-01
N208325-001	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14
N208325-001	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01
N208325-001	10344765	2034-06-27		Drug product	2019-07-19
N208325-001	11162500	2034-06-27		Drug product	2021-11-12
N208325-001	11959486	2034-06-27	U-2014	Drug product	2024-05-10
N208325-001	9820938	2034-06-27		Drug product	2017-11-29
N208325-002	8377880	2030-07-29		Drug substance, Drug product	2017-06-01
N208325-002	9278995	2030-07-29		Drug substance	2017-06-01
N208325-002	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14
N208325-002	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01
N208325-002	10344765	2034-06-27		Drug product	2019-07-19
N208325-002	11162500	2034-06-27		Drug product	2021-11-12
N208325-002	11959486	2034-06-27	U-2014	Drug product	2024-05-10
N208325-002	9820938	2034-06-27		Drug product	2017-11-29
N208325-003	8377880	2030-07-29		Drug substance, Drug product	2017-06-01
N208325-003	9278995	2030-07-29		Drug substance	2017-06-01
N208325-003	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14
N208325-003	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01
N208325-003	10344765	2034-06-27		Drug product	2019-07-19
N208325-003	11162500	2034-06-27		Drug product	2021-11-12
N208325-003	11959486	2034-06-27	U-2014	Drug product	2024-05-10
N208325-003	9820938	2034-06-27		Drug product	2017-11-29

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 24 · 924 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208325-001	8377880	2030-07-29		Drug substance, Drug product	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-001	9278995	2030-07-29		Drug substance	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-001	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-001	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-001	10344765	2034-06-27		Drug product	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-001	11162500	2034-06-27		Drug product	2021-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-001	11959486	2034-06-27	U-2014	Drug product	2024-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-001	9820938	2034-06-27		Drug product	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	8377880	2030-07-29		Drug substance, Drug product	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	9278995	2030-07-29		Drug substance	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	10344765	2034-06-27		Drug product	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	11162500	2034-06-27		Drug product	2021-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	11959486	2034-06-27	U-2014	Drug product	2024-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	9820938	2034-06-27		Drug product	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	8377880	2030-07-29		Drug substance, Drug product	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	9278995	2030-07-29		Drug substance	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	10344765	2034-06-27		Drug product	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	11162500	2034-06-27		Drug product	2021-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	11959486	2034-06-27	U-2014	Drug product	2024-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	9820938	2034-06-27		Drug product	2017-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208325-001	8377880	2030-07-29		Drug substance, Drug product	2017-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-001	9278995	2030-07-29		Drug substance	2017-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-001	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-001	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-001	10344765	2034-06-27		Drug product	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-001	11162500	2034-06-27		Drug product	2021-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-001	11959486	2034-06-27	U-2014	Drug product	2024-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-001	9820938	2034-06-27		Drug product	2017-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	8377880	2030-07-29		Drug substance, Drug product	2017-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	9278995	2030-07-29		Drug substance	2017-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	10344765	2034-06-27		Drug product	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	11162500	2034-06-27		Drug product	2021-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	11959486	2034-06-27	U-2014	Drug product	2024-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	9820938	2034-06-27		Drug product	2017-11-29	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208325-001	NCE	2022-02-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208325-002	NCE	2022-02-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208325-003	NCE	2022-02-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208325-001	NCE	2022-02-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208325-002	NCE	2022-02-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208325-003	NCE	2022-02-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208325-001	NCE	2022-02-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208325-002	NCE	2022-02-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208325-003	NCE	2022-02-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208325-001	NCE	2022-02-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208325-002	NCE	2022-02-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208325-003	NCE	2022-02-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208325-001	NCE	2022-02-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208325-002	NCE	2022-02-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208325-003	NCE	2022-02-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208325-001	NCE	2022-02-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208325-002	NCE	2022-02-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208325-003	NCE	2022-02-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208325-001	NCE	2022-02-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208325-002	NCE	2022-02-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208325-003	NCE	2022-02-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208325-001	NCE	2022-02-07	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208325-002	NCE	2022-02-07	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208325-003	NCE	2022-02-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208325-001	NCE	2022-02-07	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208325-002	NCE	2022-02-07	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208325-003	NCE	2022-02-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208325-001	NCE	2022-02-07	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208325-002	NCE	2022-02-07	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208325-003	NCE	2022-02-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208325-001	NCE	2022-02-07	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208325-002	NCE	2022-02-07	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208325-003	NCE	2022-02-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208325-001	NCE	2022-02-07	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208325-002	NCE	2022-02-07	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208325-003	NCE	2022-02-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208325-001	NCE	2022-02-07	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208325-002	NCE	2022-02-07	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208325-003	NCE	2022-02-07	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N208325-001	NCE	2022-02-07	`3bdfa0b2c4d7…`

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
PARSABIV	ETELCALCETIDE	Amgen, Inc	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	2026-03-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208325 application number: NDA208325 ndc (product): 55513-742 ndc (product): 55513-740 ndc (product): 55513-741

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55513-740	PARSABIV	etelcalcetide	Amgen Inc	NDA	Current
55513-740	PARSABIV	etelcalcetide	Amgen Inc	NDA	Current
55513-740	PARSABIV	etelcalcetide	Amgen Inc	NDA	Current
55513-740	PARSABIV	etelcalcetide	Amgen Inc	NDA	Current
55513-740	PARSABIV	etelcalcetide	Amgen Inc	NDA	Current
55513-741	PARSABIV	etelcalcetide	Amgen Inc	NDA	Current
55513-741	PARSABIV	etelcalcetide	Amgen Inc	NDA	Current
55513-741	PARSABIV	etelcalcetide	Amgen Inc	NDA	Current
55513-741	PARSABIV	etelcalcetide	Amgen Inc	NDA	Current
55513-741	PARSABIV	etelcalcetide	Amgen Inc	NDA	Current
55513-742	PARSABIV	etelcalcetide	Amgen Inc	NDA	Current
55513-742	PARSABIV	etelcalcetide	Amgen Inc	NDA	Current
55513-742	PARSABIV	etelcalcetide	Amgen Inc	NDA	Current
55513-742	PARSABIV	etelcalcetide	Amgen Inc	NDA	Current
55513-742	PARSABIV	etelcalcetide	Amgen Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66210	SUPPL	2021-02-16
57962	SUPPL	2019-03-12
57957	SUPPL	2019-03-12
55324	SUPPL	2018-08-27
55255	SUPPL	2018-08-21
47628	ORIG	2017-03-21
47138	ORIG	2017-02-08
47131	ORIG	2017-02-08