FDA.reportPublic FDA data

Application 077693

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CALCIUM ACETATECALCIUM ACETATETABLET;ORAL667MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077693-001CALCIUM ACETATECALCIUM ACETATE667MGTABLET / ORAL2008-01-30

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A077693-001CALCIUM ACETATE667MGTABLET / ORAL2008-01-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077693-001CALCIUM ACETATE667MGTABLET / ORAL2008-01-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077693-001CALCIUM ACETATE667MGTABLET / ORAL2008-01-30a50c72e98297…

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 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium AcetateCALCIUM ACETATEAmerican Health Packaging2072d9f4-abb1-4699-bde5-6041dd79cad52026-09-04Warnings, Adverse reactionsName fallback
brand name: Calcium Acetate
generic name: CALCIUM ACETATE
calcium acetateCALCIUM ACETATEREMEDYREPACK INC.89a2ee04-1024-4a81-ba0d-a6655d5298272026-09-03Warnings, Adverse reactionsName fallback
brand name: calcium acetate
generic name: CALCIUM ACETATE
Calcium AcetateCALCIUM ACETATEAvPAK52e35dd6-db95-98e6-e063-6294a90ab8012026-05-28Warnings, Adverse reactionsName fallback
brand name: Calcium Acetate
generic name: CALCIUM ACETATE
Calcium AcetateCALCIUM ACETATERising Pharma Holdings, Inc.ce650ba5-fb42-e444-e053-2a95a90a075a2026-05-15Warnings, Adverse reactionsName fallback
brand name: Calcium Acetate
generic name: CALCIUM ACETATE
Calcium AcetateCALCIUM ACETATENCS HealthCare of KY, LLC dba Vangard Labs7177829c-bd89-485c-b5e3-15e457e969c52026-04-17Warnings, Adverse reactionsName fallback
brand name: Calcium Acetate
generic name: CALCIUM ACETATE
Calcium AcetateCALCIUM ACETATECardinal Health 107, LLCa23b6070-eb4b-48e3-b563-8232206a6be42026-04-15Warnings, Adverse reactionsName fallback
brand name: Calcium Acetate
generic name: CALCIUM ACETATE
Calcium AcetateCALCIUM ACETATEMajor Pharmaceuticals9a731cdf-6488-44ca-b97f-512a0e9deab12026-03-17Warnings, Adverse reactionsName fallback
brand name: Calcium Acetate
generic name: CALCIUM ACETATE
Calcium AcetateCALCIUM ACETATEWestminster Pharmaceuticals, LLC1195f5d5-db91-4b9e-86ad-be340b43d6902026-02-24Warnings, Adverse reactionsName fallback
brand name: Calcium Acetate
generic name: CALCIUM ACETATE
Calcium AcetateCALCIUM ACETATEAmerican Health Packaging1090762c-eec1-4ab0-9ddc-43caa764cd0e2026-01-08Warnings, Adverse reactionsName fallback
brand name: Calcium Acetate
generic name: CALCIUM ACETATE
Calcium AcetateCALCIUM ACETATEPD-Rx Pharmaceuticals, Inc.925918d5-9f89-4f2f-9bb9-d9c53d90bb0a2025-10-14Warnings, Adverse reactionsName fallback
brand name: Calcium Acetate
generic name: CALCIUM ACETATE
calcium acetateCALCIUM ACETATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.d48c66a9-26fe-4e1a-a68a-88afe83fb51d2025-07-01Warnings, Adverse reactionsName fallback
brand name: calcium acetate
generic name: CALCIUM ACETATE
calcium acetateCALCIUM ACETATEAvKARE35a6f515-dfe7-031c-e063-6294a90a5e952025-06-04Warnings, Adverse reactionsName fallback
brand name: calcium acetate
generic name: CALCIUM ACETATE
Calcium AcetateCALCIUM ACETATEProficient Rx LP80c15366-9420-41c2-8817-b9c39ddfcec12025-06-01Warnings, Adverse reactionsName fallback
brand name: Calcium Acetate
generic name: CALCIUM ACETATE
Calcium AcetateCALCIUM ACETATEHikma Pharmaceuticals USA Inc.85fd41f8-2823-44ca-a15e-f1f2e5d0ff942025-04-17Warnings, Adverse reactionsName fallback
brand name: Calcium Acetate
generic name: CALCIUM ACETATE
Calcium AcetateCALCIUM ACETATEChartwell RX LLC9584350a-b6ad-45ae-b1c5-c8ca8f471c032024-10-14Warnings, Adverse reactionsName fallback
brand name: Calcium Acetate
generic name: CALCIUM ACETATE
Calcium AcetateCALCIUM ACETATENivagen Pharmaceuticals, Inc.da6dc42d-1ae6-45ff-8a81-20a7135f8d172023-12-05Warnings, Adverse reactionsName fallback
brand name: Calcium Acetate
generic name: CALCIUM ACETATE
Calcium AcetateCALCIUM ACETATEChartwell RX, LLC.781c3f1f-b622-418b-8c0e-3407e9b906562023-10-03Warnings, Adverse reactionsName fallback
brand name: Calcium Acetate
generic name: CALCIUM ACETATE
CALCIUM ACETATECALCIUM ACETATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ac4975aa-0ee9-4473-81e2-839f1556e6842023-07-28Warnings, Adverse reactionsName fallback
brand name: CALCIUM ACETATE
generic name: CALCIUM ACETATE
Calcium AcetateCALCIUM ACETATESQUARE PHARMACEUTICALS LIMITED5af79d16-31ad-4d68-9a6d-bb5d9c91535d2023-07-03Warnings, Adverse reactionsName fallback
brand name: Calcium Acetate
generic name: CALCIUM ACETATE
Calcium AcetateCALCIUM ACETATECipla USA Inc.,000c044a-12ef-4484-942e-99552b777d582021-06-01Warnings, Adverse reactionsName 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.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31278ORIG2008-01-31