Application 203135

Type: ANDA
Sponsor: INVAGEN 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
A203135-001	CALCIUM ACETATE	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203135-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	RS	2013-02-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203135-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2013-02-07	`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	A203135-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203135-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203135-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203135-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203135-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203135-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203135-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203135-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203135-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203135-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203135-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203135-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203135-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203135-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203135-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203135-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203135-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203135-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203135-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203135-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203135-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203135-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203135-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203135-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203135-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203135-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203135-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203135-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203135-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203135-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203135-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203135-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203135-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203135-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203135-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203135-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203135-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203135-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203135-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203135-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcium Acetate	CALCIUM ACETATE	American Health Packaging	2072d9f4-abb1-4699-bde5-6041dd79cad5	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203135 application number: ANDA203135
Calcium Acetate	CALCIUM ACETATE	Cipla USA Inc.,	000c044a-12ef-4484-942e-99552b777d58	2021-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203135 application number: ANDA203135 ndc (product): 69097-862
Calcium Acetate	CALCIUM ACETATE	EXELAN PHARMACEUTICALS, INC.	a5725f95-621e-425b-946d-434b3fec24eb	2021-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203135 application number: ANDA203135 ndc (product): 76282-377

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8364	Calcium Acetate	Calcium Acetate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
17856-0377	Calcium Acetate	Calcium Acetate	Atlantic Biologicals Corps	ANDA	Current
31722-377	Calcium Acetate	Calcium Acetate	Camber Pharmaceuticals, Inc.	ANDA	Current
53808-1001	Calcium Acetate	Calcium Acetate	State of Florida DOH Central Pharmacy	ANDA	Current
53808-1103	Calcium Acetate	Calcium Acetate	DOH CENTRAL PHARMACY	ANDA	Current
69097-862	Calcium Acetate	Calcium Acetate	Cipla USA Inc.,	ANDA	Current
69097-862	Calcium Acetate	Calcium Acetate	Cipla USA Inc.,	ANDA	Current
69097-862	Calcium Acetate	Calcium Acetate	Cipla USA Inc.,	ANDA	Current
69097-862	Calcium Acetate	Calcium Acetate	Cipla USA Inc.,	ANDA	Current
71335-0529	Calcium Acetate	Calcium Acetate	Bryant Ranch Prepack	ANDA	Current
71335-0529	Calcium Acetate	Calcium Acetate	Bryant Ranch Prepack	ANDA	Current
71335-0529	Calcium Acetate	Calcium Acetate	Bryant Ranch Prepack	ANDA	Current
76282-377	Calcium Acetate	Calcium Acetate	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-377	Calcium Acetate	Calcium Acetate	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-377	Calcium Acetate	Calcium Acetate	Exelan Pharmaceuticals, Inc.	ANDA	Current