FDA.reportPublic FDA data

Application 219619

Type
ANDA
Sponsor
SAGENT

Application Products#

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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219619-001CALCIUM GLUCONATE IN SODIUM CHLORIDECALCIUM GLUCONATE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSAP2025-12-30
A219619-002CALCIUM GLUCONATE IN SODIUM CHLORIDECALCIUM GLUCONATE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSAP2025-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A219619-001AP
A219619-002AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A219619-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSAP2025-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07A219619-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSAP2025-12-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219619-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSAP2025-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219619-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSAP2025-12-30011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219619-001CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML)SOLUTION / INTRAVENOUSAP2025-12-30a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219619-002CALCIUM GLUCONATE IN SODIUM CHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSAP2025-12-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219619-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A219619-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219619-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219619-002AP1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219619-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219619-002AP1a50c72e98297…

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 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
calcium gluconateCALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited787603c6-3f50-473a-8e3b-71dcf6d869642026-06-23Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEGLENMARK PHARMACEUTICALS INC., USAb2470072-f443-4596-ae33-1b8b0d05bc9d2026-06-11Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC8b77c3d2-992d-4261-8421-9cfd07328fbf2026-05-18Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATECaplin Steriles Limitedf28e9871-d546-4b48-ac3d-aead0d4c04492026-05-13Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited13d7cfc9-ff7a-437e-8c21-d9709ac07d482026-05-12Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEWG Critical Care, LLC16307c00-d0d5-4e05-821f-17b0c1a29fc92026-05-12Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEHenry Schein, Inc.3cbf6bf7-2415-4435-b3df-41855514a05d2025-12-23Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEHenry Schein, Inc.841ea51f-dc0d-45ed-8b55-bb64640cb9302025-11-03Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEREMEDYREPACK INC.4c635f60-7868-46d5-b932-d5cf8fc844322025-09-29Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEProPharma Distribution38413366-b558-7dd0-e063-6394a90acb7e2025-07-18Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEREMEDYREPACK INC.d6db3a1c-ed02-48fc-9134-ea1d58acf42e2025-06-12Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATECALCIUM GLUCONATESomerset Therapeutics, LLCfb40eba7-04e5-40dc-8a95-5f45e7bd70bc2025-02-06Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC1aaf5c76-e526-4d8b-887e-cc3c4f39cc8b2024-08-21Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC7f5101e0-abf9-4fcf-8986-c799e33334342024-05-06Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATECALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited8ee79b4c-21d3-4742-ae37-e2f5629177062024-04-18Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATECALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirst788ab6d7-d80c-0220-e053-2991aa0ae6e92024-02-01Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium Gluconate in Sodium ChlorideCALCIUM GLUCONATEWG Critical Care, LLC0deed071-d89d-420e-b4b4-797dce0ad8f02023-11-30Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate in Sodium Chloride
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.8ec4d137-1e9b-40e2-aeb2-8f62626a8fa52023-09-01Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.ce7becd8-cf59-4470-aac8-82761a24ebd72023-09-01Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.313a4ea9-178b-495e-9bc7-af1860fa65012023-05-26Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE