FDA.reportPublic FDA data

Application 216435

Type
ANDA
Sponsor
CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EDETATE CALCIUM DISODIUMEDETATE CALCIUM DISODIUMINJECTABLE;INJECTION200MG/MLNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A216435-001EDETATE CALCIUM DISODIUMEDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-03

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
2026-02-19 14:30 UTC2026-02A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-038072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-033f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216435-001EDETATE CALCIUM DISODIUM200MG/MLINJECTABLE / INJECTIONRS2023-05-03a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216435-001CGT2024-01-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216435-001CGT2024-01-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216435-001CGT2024-01-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216435-001CGT2024-01-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216435-001CGT2024-01-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216435-001CGT2024-01-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216435-001CGT2024-01-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216435-001CGT2024-01-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216435-001CGT2024-01-088072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216435-001CGT2024-01-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216435-001CGT2024-01-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216435-001CGT2024-01-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216435-001CGT2024-01-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216435-001CGT2024-01-089b2671bbb829…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Edetate Calcium DisodiumEDETATE CALCIUM DISODIUMRising Pharma Holdings, Inc.710a2c8c-3620-4f6f-b8fc-fb19ab9e9f222025-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216435
application number: ANDA216435

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74518ORIG 2023-06-16