Application 203298

Type: ANDA
Sponsor: LOTUS PHARM CO LTD

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 43.

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
A203298-001	CALCIUM ACETATE	CALCIUM ACETATE	667MG	CAPSULE / ORAL			2016-07-26

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 · 43 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
2026-09-14 22:38:34	2026-08	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2016-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2016-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2016-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2016-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203298-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2016-07-26	`f41ea6bd6efb…`

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	A203298-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A203298-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203298-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203298-001	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 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 brand name: Calcium Acetate 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 brand name: Calcium Acetate 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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-629	Calcium Acetate	Calcium Acetate	Marlex Pharmaceuticals Inc	ANDA	Current
10135-629	Calcium Acetate	Calcium Acetate	Marlex Pharmaceuticals Inc	ANDA	Current
40051-049	Calcium Acetate	Calcium Acetate	Lotus Pharmaceutical Co., Ltd. Nantou Plant	ANDA	Current
40051-049	Calcium Acetate	Calcium Acetate	Lotus Pharmaceutical Co., Ltd. Nantou Plant	ANDA	Current
51293-825	Calcium Acetate	Calcium Acetate	ECI Pharmaceuticals, LLC	ANDA	Current
51293-825	Calcium Acetate	Calcium Acetate	ECI Pharmaceuticals, LLC	ANDA	Current