Application 077728

Type: ANDA
Sponsor: HIKMA

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
A077728-001	CALCIUM ACETATE	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2008-02-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A077728-001	AB

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	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077728-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077728-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077728-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077728-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077728-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077728-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077728-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077728-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077728-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077728-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077728-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077728-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077728-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077728-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077728-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077728-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077728-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077728-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077728-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077728-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077728-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077728-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077728-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077728-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077728-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077728-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077728-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077728-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077728-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077728-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077728-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077728-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077728-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077728-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077728-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077728-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077728-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077728-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077728-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077728-001	AB	1	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcium Acetate	CALCIUM ACETATE	Cardinal Health 107, LLC	a23b6070-eb4b-48e3-b563-8232206a6be4	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077728 application number: ANDA077728
Calcium Acetate	CALCIUM ACETATE	Major Pharmaceuticals	9a731cdf-6488-44ca-b97f-512a0e9deab1	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077728 application number: ANDA077728 ndc (product): 0904-7119
Calcium Acetate	CALCIUM ACETATE	American Health Packaging	1090762c-eec1-4ab0-9ddc-43caa764cd0e	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077728 application number: ANDA077728 ndc (product): 68084-479
Calcium Acetate	CALCIUM ACETATE	Hikma Pharmaceuticals USA Inc.	85fd41f8-2823-44ca-a15e-f1f2e5d0ff94	2025-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077728 application number: ANDA077728 ndc (product): 0054-0088

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0088	Calcium Acetate	Calcium Acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0088	Calcium Acetate	Calcium Acetate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0615-2303	Calcium Acetate	Calcium Acetate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-7119	Calcium Acetate	Calcium Acetate	Major Pharmaceuticals	ANDA	Current
17856-0088	Calcium Acetate	Calcium Acetate	Atlantic Biologicals Corps	ANDA	Current
53808-0216	Calcium Acetate	Calcium Acetate	State of Florida DOH Central Pharmacy	ANDA	Current
55154-4984	Calcium Acetate	Calcium Acetate	Cardinal Health	ANDA	Current
55154-4984	Calcium Acetate	Calcium Acetate	Cardinal Health	ANDA	Current
55154-4984	Calcium Acetate	Calcium Acetate	Cardinal Health	ANDA	Current
68084-479	Calcium Acetate	Calcium Acetate	American Health Packaging	ANDA	Current
68084-479	Calcium Acetate	Calcium Acetate	American Health Packaging	ANDA	Current
68084-479	Calcium Acetate	Calcium Acetate	American Health Packaging	ANDA	Current
68084-479	Calcium Acetate	Calcium Acetate	American Health Packaging	ANDA	Current
71335-0172	Calcium Acetate	Calcium Acetate	Bryant Ranch Prepack	ANDA	Current
71335-0172	Calcium Acetate	Calcium Acetate	Bryant Ranch Prepack	ANDA	Current
71335-0172	Calcium Acetate	Calcium Acetate	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31283	ORIG	2008-02-27
31282	ORIG	2008-01-09