Application 210906

Type
NDA
Sponsor
HQ SPCLT PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CALCIUM GLUCONATE IN SODIUM CHLORIDECALCIUM GLUCONATESOLUTION;INTRAVENOUS1GM/50ML (20MG/ML)YesYes
002CALCIUM GLUCONATE IN SODIUM CHLORIDECALCIUM GLUCONATESOLUTION;INTRAVENOUS2GM/100ML (20MG/ML)YesYes
003CALCIUM GLUCONATE IN SODIUM CHLORIDECALCIUM GLUCONATESOLUTION;INTRAVENOUS1GM/100ML (10MG/ML)YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210906-001CALCIUM GLUCONATE IN SODIUM CHLORIDECALCIUM GLUCONATE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29
N210906-002CALCIUM GLUCONATE IN SODIUM CHLORIDECALCIUM GLUCONATE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29
N210906-003CALCIUM GLUCONATE IN SODIUM CHLORIDECALCIUM GLUCONATE1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-06-04
N210906-004CALCIUM GLUCONATECALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-11-18

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210906-001101306462037-07-25Drug product2018-11-20
N210906-001103428132037-07-25Drug product2019-07-31
N210906-002101306462037-07-25Drug product2018-11-20
N210906-002103428132037-07-25Drug product2019-07-31
N210906-003101306462037-07-25Drug product2021-10-15
N210906-003103428132037-07-25Drug product2021-10-15

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 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N210906-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N210906-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N210906-003CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-06-04caaa826d4ba7…
2026-08-18 06:07:402026-07N210906-004CALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-11-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210906-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210906-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210906-003CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-06-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210906-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210906-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210906-003CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-06-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N210906-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210906-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210906-003CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-06-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210906-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210906-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210906-003CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-06-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210906-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210906-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210906-003CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-06-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210906-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210906-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210906-003CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-06-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210906-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210906-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210906-003CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-06-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210906-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210906-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210906-003CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-06-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210906-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210906-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210906-003CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-06-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210906-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N210906-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N210906-003CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-06-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210906-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210906-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210906-003CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-06-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210906-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210906-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2018-10-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210906-003CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-06-04301d65b070ca…

Observed Orange Book patent history#

Patent history page 1 of 6 · 234 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N210906-001101306462037-07-25Drug product2018-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07N210906-001103428132037-07-25Drug product2019-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N210906-002101306462037-07-25Drug product2018-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07N210906-002103428132037-07-25Drug product2019-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N210906-003101306462037-07-25Drug product2021-10-15caaa826d4ba7…
2026-08-18 06:07:402026-07N210906-003103428132037-07-25Drug product2021-10-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210906-001101306462037-07-25Drug product2018-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210906-001103428132037-07-25Drug product2019-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210906-002101306462037-07-25Drug product2018-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210906-002103428132037-07-25Drug product2019-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210906-003101306462037-07-25Drug product2021-10-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210906-003103428132037-07-25Drug product2021-10-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210906-001101306462037-07-25Drug product2018-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210906-001103428132037-07-25Drug product2019-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210906-002101306462037-07-25Drug product2018-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210906-002103428132037-07-25Drug product2019-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210906-003101306462037-07-25Drug product2021-10-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210906-003103428132037-07-25Drug product2021-10-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N210906-001101306462037-07-25Drug product2018-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210906-001103428132037-07-25Drug product2019-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210906-002101306462037-07-25Drug product2018-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210906-002103428132037-07-25Drug product2019-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210906-003101306462037-07-25Drug product2021-10-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210906-003103428132037-07-25Drug product2021-10-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210906-001101306462037-07-25Drug product2018-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210906-001103428132037-07-25Drug product2019-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210906-002101306462037-07-25Drug product2018-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210906-002103428132037-07-25Drug product2019-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210906-003101306462037-07-25Drug product2021-10-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210906-003103428132037-07-25Drug product2021-10-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210906-001101306462037-07-25Drug product2018-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210906-001103428132037-07-25Drug product2019-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210906-002101306462037-07-25Drug product2018-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210906-002103428132037-07-25Drug product2019-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210906-003101306462037-07-25Drug product2021-10-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210906-003103428132037-07-25Drug product2021-10-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210906-001101306462037-07-25Drug product2018-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210906-001103428132037-07-25Drug product2019-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210906-002101306462037-07-25Drug product2018-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210906-002103428132037-07-25Drug product2019-07-3103ed91905a0d…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium GluconateCALCIUM GLUCONATEWG Critical Care, LLC16307c00-d0d5-4e05-821f-17b0c1a29fc92026-05-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 210906
application number: NDA210906
Calcium Gluconate in Sodium ChlorideCALCIUM GLUCONATEWG Critical Care, LLC0deed071-d89d-420e-b4b4-797dce0ad8f02023-11-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 210906
application number: NDA210906
ndc (product): 44567-621
ndc (product): 44567-620
Calcium Gluconate in Sodium ChlorideCALCIUM GLUCONATEWG Critical Care, LLCe6d531ec-fcdc-49f6-b0c4-878d3952827f2021-10-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 210906
application number: NDA210906
ndc (product): 44567-621
ndc (product): 44567-622
ndc (product): 44567-620

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-622Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-622Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-622Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65121SUPPL2020-11-02
65074SUPPL2020-10-29
56751ORIG2018-12-17
56214ORIG2018-10-31
56203ORIG2018-10-31