Application 021160

Type: NDA
Sponsor: FRESENIUS MEDCL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHOSLO	CALCIUM ACETATE	CAPSULE;ORAL	333.5MG	No	No
002	PHOSLO	CALCIUM ACETATE	CAPSULE;ORAL	667MG	No	No
003	PHOSLO GELCAPS	CALCIUM ACETATE	CAPSULE;ORAL	667MG	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
N021160-001	PHOSLO	CALCIUM ACETATE	333.5MG	CAPSULE / ORAL		2001-04-02
N021160-002	PHOSLO	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2001-04-02
N021160-003	PHOSLO GELCAPS	CALCIUM ACETATE	667MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2001-04-02

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 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	N021160-001	PHOSLO	333.5MG	CAPSULE / ORAL		2001-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021160-002	PHOSLO	667MG	CAPSULE / ORAL		2001-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021160-003	PHOSLO GELCAPS	667MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2001-04-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021160-001	PHOSLO	333.5MG	CAPSULE / ORAL		2001-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021160-002	PHOSLO	667MG	CAPSULE / ORAL		2001-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021160-003	PHOSLO GELCAPS	667MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2001-04-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021160-001	PHOSLO	333.5MG	CAPSULE / ORAL		2001-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021160-002	PHOSLO	667MG	CAPSULE / ORAL		2001-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021160-003	PHOSLO GELCAPS	667MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2001-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021160-001	PHOSLO	333.5MG	CAPSULE / ORAL		2001-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021160-002	PHOSLO	667MG	CAPSULE / ORAL		2001-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021160-003	PHOSLO GELCAPS	667MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2001-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021160-001	PHOSLO	333.5MG	CAPSULE / ORAL		2001-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021160-002	PHOSLO	667MG	CAPSULE / ORAL		2001-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021160-003	PHOSLO GELCAPS	667MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2001-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021160-001	PHOSLO	333.5MG	CAPSULE / ORAL		2001-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021160-002	PHOSLO	667MG	CAPSULE / ORAL		2001-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021160-003	PHOSLO GELCAPS	667MG	CAPSULE / ORAL	RLD	2001-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021160-001	PHOSLO	333.5MG	CAPSULE / ORAL		2001-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021160-002	PHOSLO	667MG	CAPSULE / ORAL		2001-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021160-003	PHOSLO GELCAPS	667MG	CAPSULE / ORAL	RLD	2001-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021160-001	PHOSLO	333.5MG	CAPSULE / ORAL		2001-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021160-002	PHOSLO	667MG	CAPSULE / ORAL		2001-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021160-003	PHOSLO GELCAPS	667MG	CAPSULE / ORAL	RLD	2001-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021160-001	PHOSLO	333.5MG	CAPSULE / ORAL		2001-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021160-002	PHOSLO	667MG	CAPSULE / ORAL		2001-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021160-003	PHOSLO GELCAPS	667MG	CAPSULE / ORAL	RLD	2001-04-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021160-001	PHOSLO	333.5MG	CAPSULE / ORAL		2001-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021160-002	PHOSLO	667MG	CAPSULE / ORAL		2001-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021160-003	PHOSLO GELCAPS	667MG	CAPSULE / ORAL	RLD	2001-04-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021160-001	PHOSLO	333.5MG	CAPSULE / ORAL		2001-04-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021160-002	PHOSLO	667MG	CAPSULE / ORAL		2001-04-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021160-003	PHOSLO GELCAPS	667MG	CAPSULE / ORAL	RLD	2001-04-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021160-001	PHOSLO	333.5MG	CAPSULE / ORAL		2001-04-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021160-002	PHOSLO	667MG	CAPSULE / ORAL		2001-04-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021160-003	PHOSLO GELCAPS	667MG	CAPSULE / ORAL	RLD	2001-04-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021160-001	PHOSLO	333.5MG	CAPSULE / ORAL		2001-04-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021160-002	PHOSLO	667MG	CAPSULE / ORAL		2001-04-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021160-003	PHOSLO GELCAPS	667MG	CAPSULE / ORAL	RLD	2001-04-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021160-001	PHOSLO	333.5MG	CAPSULE / ORAL		2001-04-02	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021160-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021160-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021160-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021160-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021160-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021160-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021160-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021160-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021160-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021160-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021160-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021160-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021160-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021160-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021160-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021160-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021160-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021160-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021160-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021160-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021160-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021160-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021160-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021160-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021160-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021160-003	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021160-002	6576665	2021-04-03			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021160-003	6576665	2021-04-03			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021160-003	6875445	2021-07-30	Drug product	2015-03-17	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021160-002	6576665	2021-04-03			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021160-003	6576665	2021-04-03			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021160-003	6875445	2021-07-30	Drug product	2015-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021160-002	6576665	2021-04-03			`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021160-003	6576665	2021-04-03			`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021160-003	6875445	2021-07-30	Drug product	2015-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021160-002	6576665	2021-04-03			`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021160-003	6576665	2021-04-03			`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021160-003	6875445	2021-07-30	Drug product	2015-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021160-002	6576665	2021-04-03			`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021160-003	6576665	2021-04-03			`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021160-003	6875445	2021-07-30	Drug product	2015-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021160-002	6576665	2021-04-03			`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021160-003	6576665	2021-04-03			`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021160-003	6875445	2021-07-30	Drug product	2015-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021160-002	6576665	2021-04-03			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021160-003	6576665	2021-04-03			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021160-003	6875445	2021-07-30	Drug product	2015-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021160-002	6576665	2021-04-03			`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021160-003	6576665	2021-04-03			`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021160-003	6875445	2021-07-30	Drug product	2015-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021160-002	6576665	2021-04-03			`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021160-003	6576665	2021-04-03			`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021160-003	6875445	2021-07-30	Drug product	2015-03-17	`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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcium Acetate	CALCIUM ACETATE	EXELAN PHARMACEUTICALS, INC.	a5725f95-621e-425b-946d-434b3fec24eb	2021-06-01	Warnings, Adverse reactions	Name fallback generic name: CALCIUM ACETATE
Calcium Acetate	CALCIUM ACETATE	Amneal Pharmaceuticals of New York LLC	4a490e1d-80ee-461f-aba6-01f54fe8a5fe	2020-07-31	Warnings, Adverse reactions	Name fallback generic name: CALCIUM ACETATE

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 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-2081	Calcium Acetate	Calcium Acetate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2081	Calcium Acetate	Calcium Acetate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2081	Calcium Acetate	Calcium Acetate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2081	Calcium Acetate	Calcium Acetate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2081	Calcium Acetate	Calcium Acetate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2081	Calcium Acetate	Calcium Acetate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2672	Calcium Acetate	Calcium Acetate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2672	Calcium Acetate	Calcium Acetate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2672	Calcium Acetate	Calcium Acetate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2672	Calcium Acetate	Calcium Acetate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2672	Calcium Acetate	Calcium Acetate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2672	Calcium Acetate	Calcium Acetate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
49230-640	PhosLo	Calcium Acetate	Fresenius Medical Care North America	NDA	Current
49230-640	PhosLo	Calcium Acetate	Fresenius Medical Care North America	NDA	Current
49230-640	PhosLo	Calcium Acetate	Fresenius Medical Care North America	NDA	Current
49230-640	PhosLo	Calcium Acetate	Fresenius Medical Care North America	NDA	Current
49230-640	PhosLo	Calcium Acetate	Fresenius Medical Care North America	NDA	Current
49230-644	Calcium Acetate	Calcium Acetate	Fresenius Medical Care North America	NDA AUTHORIZED GENERIC	Current
49230-644	Calcium Acetate	Calcium Acetate	Fresenius Medical Care North America	NDA AUTHORIZED GENERIC	Current
49230-644	Calcium Acetate	Calcium Acetate	Fresenius Medical Care North America	NDA AUTHORIZED GENERIC	Current
49230-644	Calcium Acetate	Calcium Acetate	Fresenius Medical Care North America	NDA AUTHORIZED GENERIC	Current
53808-0905	Calcium Acetate	Calcium Acetate	State of Florida DOH Central Pharmacy	NDA AUTHORIZED GENERIC	Current
70518-2372	Calcium Acetate	Calcium Acetate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2372	Calcium Acetate	Calcium Acetate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2372	Calcium Acetate	Calcium Acetate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2372	Calcium Acetate	Calcium Acetate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2372	Calcium Acetate	Calcium Acetate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
71335-1351	Calcium Acetate	Calcium Acetate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-1351	Calcium Acetate	Calcium Acetate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47810	SUPPL	2017-03-30
4506	SUPPL	2011-03-31
26939	SUPPL	2004-03-02
41995	ORIG	2001-04-02
36244	ORIG	2001-04-02
4505	ORIG	2001-04-02