FDA.reportPublic FDA data

Application 084916

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEINJECTABLE;INJECTIONEQ 4MG PHOSPHATE/MLNoYes

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

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
A084916-001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A084916-001AP

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A084916-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A084916-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084916-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A084916-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A084916-001AP1c2088c7a36db…
2026-09-14 22:38:342026-08A084916-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A084916-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A084916-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084916-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A084916-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084916-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084916-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084916-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084916-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084916-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084916-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084916-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084916-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084916-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084916-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084916-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084916-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084916-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084916-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084916-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084916-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084916-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084916-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A084916-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084916-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084916-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084916-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A084916-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A084916-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084916-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084916-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084916-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084916-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084916-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084916-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084916-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A084916-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A084916-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084916-001AP13a93d1ddd44b…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESportpharm LLC9822a5c3-d3f1-4e0b-9963-32b22740e10e2026-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084916
application number: ANDA084916
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLC2b626a48-c7aa-4443-9164-a08ff069ccd12026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084916
application number: ANDA084916
ndc (product): 63323-165
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATECardinal Health 107, LLC6d3cbd54-93ef-40fe-b15a-7a4f52dc5f712026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084916
application number: ANDA084916
ndc (product): 55154-9364
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEA-S Medication Solutions3c05089c-5a25-40c3-9abc-b2e40696bcdc2025-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084916
application number: ANDA084916
ndc (product): 50090-0414
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLC4fedef4f-ec96-4f36-b2f0-01e243e3b89e2024-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084916
application number: ANDA084916
ndc (product): 63323-165
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEPhlow Corporation02d25ab8-8f51-452b-b944-f569fbae36fe2024-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084916
application number: ANDA084916
ndc (product): 81565-202
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirst94cb045b-5801-db32-e053-2a95a90a93ef2022-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084916
application number: ANDA084916
ndc (product): 51662-1370

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-0414Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEA-S Medication SolutionsANDACurrent
50090-0627Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEA-S Medication SolutionsANDACurrent
51662-1370DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1370DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1370DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
55154-9364Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATECardinal HealthANDACurrent
55154-9364Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATECardinal Health 107, LLCANDACurrent
63323-165Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLCANDACurrent
63323-165Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLCANDACurrent
63323-165Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLCANDACurrent
68071-4580Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATENuCare Pharmaceuticals,Inc.ANDACurrent
70518-0621Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEREMEDYREPACK INC.ANDACurrent
70518-0872Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEREMEDYREPACK INC.ANDACurrent
70529-112Neuromaquel Neuroma/Anti-Inflammatory SystemDEXAMETHASONE SODIUM PHOSPHATEIT3 Medical LLCANDACurrent
70529-112Neuromaquel Neuroma/Anti-Inflammatory SystemDEXAMETHASONE SODIUM PHOSPHATEIT3 Medical LLCANDACurrent
70529-112Neuromaquel Neuroma/Anti-Inflammatory SystemDEXAMETHASONE SODIUM PHOSPHATEIT3 Medical LLCANDACurrent
70529-118Cortaren Corticosteroid/Anti-Inflammatory SystemDEXAMETHASONE SODIUM PHOSPHATEIT3 Medical LLCANDACurrent
70529-118Cortaren Corticosteroid/Anti-Inflammatory SystemDEXAMETHASONE SODIUM PHOSPHATEIT3 Medical LLCANDACurrent
70529-118Cortaren Corticosteroid/Anti-Inflammatory SystemDEXAMETHASONE SODIUM PHOSPHATEIT3 Medical LLCANDACurrent
81565-202Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEPhlow CorporationANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9243SUPPL2015-07-28
18506SUPPL2015-07-27