Application 201658

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALCIUM ACETATE	CALCIUM ACETATE	CAPSULE;ORAL	667MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201658-001	CALCIUM ACETATE	CALCIUM ACETATE	667MG	CAPSULE / ORAL			2014-10-06

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 2 · 42 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	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A201658-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201658-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201658-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201658-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201658-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201658-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201658-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201658-001	AB	1	`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
Calcium Acetate	CALCIUM ACETATE	Amneal Pharmaceuticals of New York LLC	4a490e1d-80ee-461f-aba6-01f54fe8a5fe	2020-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201658 application number: ANDA201658 ndc (product): 53746-590

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8090	Calcium Acetate	Calcium Acetate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8090	Calcium Acetate	Calcium Acetate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8090	Calcium Acetate	Calcium Acetate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6546	Calcium Acetate	Calcium Acetate	Major Pharmaceuticals	ANDA	Current
0904-6546	Calcium Acetate	Calcium Acetate	Major Pharmaceuticals	ANDA	Current
42291-189	Calcium Acetate	Calcium Acetate	AvKARE, Inc.	ANDA	Current
42291-189	Calcium Acetate	Calcium Acetate	AvKARE, Inc.	ANDA	Current
50268-148	Calcium Acetate	Calcium Acetate	AvPAK	ANDA	Current
50268-148	Calcium Acetate	Calcium Acetate	AvPAK	ANDA	Current
53746-590	Calcium Acetate	Calcium Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-590	Calcium Acetate	Calcium Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
55154-7880	Calcium Acetate	Calcium Acetate	Cardinal Health	ANDA	Current
55154-7880	Calcium Acetate	Calcium Acetate	Cardinal Health	ANDA	Current
65162-590	Calcium Acetate	Calcium Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-590	Calcium Acetate	Calcium Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-590	Calcium Acetate	Calcium Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-590	Calcium Acetate	Calcium Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
68094-002	Calcium Acetate	Calcium Acetate	Precision Dose, Inc.	ANDA	Current
68094-002	Calcium Acetate	Calcium Acetate	Precision Dose, Inc.	ANDA	Current
70518-1277	Calcium Acetate	Calcium Acetate	REMEDYREPACK INC.	ANDA	Current
70518-1277	Calcium Acetate	Calcium Acetate	REMEDYREPACK INC.	ANDA	Current
71335-0621	Calcium Acetate	Calcium Acetate	Bryant Ranch Prepack	ANDA	Current