Application 204364

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A204364-001	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2021-12-02
A204364-002	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	2021-12-02
A204364-003	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	2021-12-02

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 2 of 3 · 108 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL		2021-12-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL		2021-12-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL		2021-12-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL		2021-12-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL		2021-12-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL		2021-12-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL		2021-12-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL		2021-12-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL		2021-12-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL		2021-12-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL		2021-12-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL		2021-12-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL		2021-12-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL		2021-12-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL		2021-12-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL		2021-12-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL		2021-12-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL		2021-12-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL		2021-12-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL		2021-12-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2021-12-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-12-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2021-12-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2021-12-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-12-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2021-12-02	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL		2021-12-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL		2021-12-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL		2021-12-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL		2021-12-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL		2021-12-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL		2021-12-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL		2021-12-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL		2021-12-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL		2021-12-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL		2021-12-02	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL		2021-12-02	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL		2021-12-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL		2021-12-02	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL		2021-12-02	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A204364-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204364-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204364-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204364-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204364-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204364-003	AB	1	`782e0a99824c…`

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
Cinacalcet Hydrochloride	CINACALCET	Amneal Pharmaceuticals LLC	28262843-b0a8-4ca7-8b92-41b7f0e896b4	2021-08-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204364 application number: ANDA204364 ndc (product): 65162-157 ndc (product): 65162-213 ndc (product): 65162-155

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-155	Cinacalcet Hydrochloride	Cinacalcet	Amneal Pharmaceuticals LLC	ANDA	Current
65162-155	Cinacalcet Hydrochloride	Cinacalcet	Amneal Pharmaceuticals LLC	ANDA	Current
65162-157	Cinacalcet Hydrochloride	Cinacalcet	Amneal Pharmaceuticals LLC	ANDA	Current
65162-157	Cinacalcet Hydrochloride	Cinacalcet	Amneal Pharmaceuticals LLC	ANDA	Current
65162-213	Cinacalcet Hydrochloride	Cinacalcet	Amneal Pharmaceuticals LLC	ANDA	Current
65162-213	Cinacalcet Hydrochloride	Cinacalcet	Amneal Pharmaceuticals LLC	ANDA	Current