Application 210906

Type: NDA
Sponsor: HQ SPCLT PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	SOLUTION;INTRAVENOUS	1GM/50ML (20MG/ML)	Yes	Yes
002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	SOLUTION;INTRAVENOUS	2GM/100ML (20MG/ML)	Yes	Yes
003	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	SOLUTION;INTRAVENOUS	1GM/100ML (10MG/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29
N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29
N210906-003	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-04
N210906-004	CALCIUM GLUCONATE	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-11-18

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N210906-001	10130646	2037-07-25	Drug product	2018-11-20
N210906-001	10342813	2037-07-25	Drug product	2019-07-31
N210906-002	10130646	2037-07-25	Drug product	2018-11-20
N210906-002	10342813	2037-07-25	Drug product	2019-07-31
N210906-003	10130646	2037-07-25	Drug product	2021-10-15
N210906-003	10342813	2037-07-25	Drug product	2021-10-15

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 2 of 4 · 128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-10-29 15:01 UTC	2024-10	N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210906-003	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210906-003	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210906-003	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210906-003	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210906-003	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210906-003	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210906-003	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210906-003	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210906-003	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210906-003	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210906-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210906-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-10-29	`3f01610625f2…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N210906-001	10130646	2037-07-25	Drug product	2018-11-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210906-001	10342813	2037-07-25	Drug product	2019-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210906-002	10130646	2037-07-25	Drug product	2018-11-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210906-002	10342813	2037-07-25	Drug product	2019-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210906-003	10130646	2037-07-25	Drug product	2021-10-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210906-003	10342813	2037-07-25	Drug product	2021-10-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210906-001	10130646	2037-07-25	Drug product	2018-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210906-001	10342813	2037-07-25	Drug product	2019-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210906-002	10130646	2037-07-25	Drug product	2018-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210906-002	10342813	2037-07-25	Drug product	2019-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210906-003	10130646	2037-07-25	Drug product	2021-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210906-003	10342813	2037-07-25	Drug product	2021-10-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210906-001	10130646	2037-07-25	Drug product	2018-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210906-001	10342813	2037-07-25	Drug product	2019-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210906-002	10130646	2037-07-25	Drug product	2018-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210906-002	10342813	2037-07-25	Drug product	2019-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210906-003	10130646	2037-07-25	Drug product	2021-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210906-003	10342813	2037-07-25	Drug product	2021-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210906-001	10130646	2037-07-25	Drug product	2018-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210906-001	10342813	2037-07-25	Drug product	2019-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210906-002	10130646	2037-07-25	Drug product	2018-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210906-002	10342813	2037-07-25	Drug product	2019-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210906-003	10130646	2037-07-25	Drug product	2021-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210906-003	10342813	2037-07-25	Drug product	2021-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210906-001	10130646	2037-07-25	Drug product	2018-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210906-001	10342813	2037-07-25	Drug product	2019-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210906-002	10130646	2037-07-25	Drug product	2018-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210906-002	10342813	2037-07-25	Drug product	2019-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210906-003	10130646	2037-07-25	Drug product	2021-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210906-003	10342813	2037-07-25	Drug product	2021-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210906-001	10130646	2037-07-25	Drug product	2018-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210906-001	10342813	2037-07-25	Drug product	2019-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210906-002	10130646	2037-07-25	Drug product	2018-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210906-002	10342813	2037-07-25	Drug product	2019-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210906-003	10130646	2037-07-25	Drug product	2021-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210906-003	10342813	2037-07-25	Drug product	2021-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210906-001	10130646	2037-07-25	Drug product	2018-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210906-001	10342813	2037-07-25	Drug product	2019-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210906-002	10130646	2037-07-25	Drug product	2018-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210906-002	10342813	2037-07-25	Drug product	2019-07-31	`fd3edfee7708…`

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
calcium gluconate	CALCIUM GLUCONATE	REMEDYREPACK INC.	d6db3a1c-ed02-48fc-9134-ea1d58acf42e	2026-09-08	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
calcium gluconate	CALCIUM GLUCONATE	Amneal Pharmaceuticals Private Limited	787603c6-3f50-473a-8e3b-71dcf6d86964	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
Calcium Gluconate	CALCIUM GLUCONATE	GLENMARK PHARMACEUTICALS INC., USA	b2470072-f443-4596-ae33-1b8b0d05bc9d	2026-06-11	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
Calcium Gluconate	CALCIUM GLUCONATE	Fresenius Kabi USA, LLC	8b77c3d2-992d-4261-8421-9cfd07328fbf	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
Calcium Gluconate	CALCIUM GLUCONATE	Caplin Steriles Limited	f28e9871-d546-4b48-ac3d-aead0d4c0449	2026-05-13	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
calcium gluconate	CALCIUM GLUCONATE	Amneal Pharmaceuticals Private Limited	13d7cfc9-ff7a-437e-8c21-d9709ac07d48	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
Calcium Gluconate	CALCIUM GLUCONATE	Henry Schein, Inc.	3cbf6bf7-2415-4435-b3df-41855514a05d	2025-12-23	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
Calcium Gluconate	CALCIUM GLUCONATE	Henry Schein, Inc.	841ea51f-dc0d-45ed-8b55-bb64640cb930	2025-11-03	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
Calcium Gluconate	CALCIUM GLUCONATE	REMEDYREPACK INC.	4c635f60-7868-46d5-b932-d5cf8fc84432	2025-09-29	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
Calcium Gluconate	CALCIUM GLUCONATE	ProPharma Distribution	38413366-b558-7dd0-e063-6394a90acb7e	2025-07-18	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATE	CALCIUM GLUCONATE	Somerset Therapeutics, LLC	fb40eba7-04e5-40dc-8a95-5f45e7bd70bc	2025-02-06	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
Calcium Gluconate	CALCIUM GLUCONATE	Fresenius Kabi USA, LLC	1aaf5c76-e526-4d8b-887e-cc3c4f39cc8b	2024-08-21	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
Calcium Gluconate	CALCIUM GLUCONATE	Fresenius Kabi USA, LLC	7f5101e0-abf9-4fcf-8986-c799e3333434	2024-05-06	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATE	CALCIUM GLUCONATE	Amneal Pharmaceuticals Private Limited	8ee79b4c-21d3-4742-ae37-e2f562917706	2024-04-18	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATE	CALCIUM GLUCONATE	HF Acquisition Co LLC, DBA HealthFirst	788ab6d7-d80c-0220-e053-2991aa0ae6e9	2024-02-01	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
calcium gluconate	CALCIUM GLUCONATE	Hikma Pharmaceuticals USA Inc.	8ec4d137-1e9b-40e2-aeb2-8f62626a8fa5	2023-09-01	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
calcium gluconate	CALCIUM GLUCONATE	Hikma Pharmaceuticals USA Inc.	ce7becd8-cf59-4470-aac8-82761a24ebd7	2023-09-01	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
calcium gluconate	CALCIUM GLUCONATE	Hikma Pharmaceuticals USA Inc.	313a4ea9-178b-495e-9bc7-af1860fa6501	2023-05-26	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
Calcium Gluconate	CALCIUM GLUCONATE	Medical Purchasing Solutions, LLC	b6226367-b061-eec5-e053-2a95a90a617d	2023-05-04	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE
Calcium Gluconate	CALCIUM GLUCONATE	B. Braun Medical Inc.	af362bcb-7010-4eb5-b8c4-42aa3b0cdcde	2023-04-28	Warnings, Adverse reactions	Name fallback generic name: CALCIUM GLUCONATE

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 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44567-620	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-620	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-620	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-620	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-620	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-620	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-620	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-620	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-621	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-621	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-621	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-621	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-621	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-621	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-621	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-621	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-622	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-622	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current
44567-622	Calcium Gluconate	Calcium Gluconate	WG Critical Care, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65121	SUPPL	2020-11-02
65074	SUPPL	2020-10-29
56751	ORIG	2018-12-17
56214	ORIG	2018-10-31
56203	ORIG	2018-10-31