Application 040803

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

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

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
A040803-001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040803-001AP

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-293f01610625f2…
2019-09-15 20:21 UTC2019-09A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040803-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040803-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040803-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040803-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040803-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040803-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040803-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040803-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040803-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040803-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040803-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040803-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040803-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040803-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040803-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040803-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040803-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040803-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040803-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040803-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040803-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A040803-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040803-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040803-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040803-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A040803-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040803-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040803-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040803-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040803-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040803-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040803-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040803-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040803-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040803-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040803-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040803-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040803-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040803-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040803-001AP1cb3db0bc1861…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESportpharm LLCa8aee11f-c928-41ef-8df8-e6d8b355536c2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEHenry Schein, Inc.c464ffde-f64e-4716-92d2-720a107932482026-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEProPharma Distribution384206f5-75ed-9bd2-e063-6294a90a50382025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEProPharma Distribution42c879cc-38dc-c9bc-e063-6294a90a204d2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.36854dbc-22f2-5df9-e063-6394a90ad9342025-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEA-S Medication Solutionsd21f3055-8a8a-4797-93e2-c8f582cbdae12024-04-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
ndc (product): 50090-2313
ndc (product): 50090-1922
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMylan Institutional LLCdff598e8-e662-411f-978d-4ba3fb8ef7db2024-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
ndc (product): 67457-423
ndc (product): 67457-421
ndc (product): 67457-422
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC86091483-2053-5da8-e053-2a91aa0a6f452023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
ndc (product): 71872-7157
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC81a28bdb-b186-8047-e053-2a91aa0a4e0a2023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
ndc (product): 71872-7153
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC81a0503c-39fe-1c67-e053-2a91aa0a5b8f2023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
ndc (product): 71872-7147
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.b2ce414a-3b1f-4533-bb3a-18594529dead2020-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
ndc (product): 76420-185
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMylan Institutional LLC836f8017-d023-410b-8515-ec776e73ca592019-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
ndc (product): 67457-418
ndc (product): 67457-484
ndc (product): 67457-419

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9841Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateHenry Schein, Inc.ANDACurrent
0404-9841Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateHenry Schein, Inc.ANDACurrent
50090-1922Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateA-S Medication SolutionsANDACurrent
50090-2313Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateA-S Medication SolutionsANDACurrent
50090-2313Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateA-S Medication SolutionsANDACurrent
52584-421Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateGeneral Injectables and Vaccines, IncANDACurrent
52584-421Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateGeneral Injectables and Vaccines, IncANDACurrent
52584-421Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateGeneral Injectables and Vaccines, IncANDACurrent
52584-422Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateGeneral Injectables and Vaccines, IncANDACurrent
52584-422Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateGeneral Injectables and Vaccines, IncANDACurrent
52584-422Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateGeneral Injectables and Vaccines, IncANDACurrent
52584-422Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateGeneral Injectables and Vaccines, IncANDACurrent
55154-7075Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateCardinal HealthANDACurrent
67457-418Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMylan Institutional LLCANDACurrent
67457-419Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMylan Institutional LLCANDACurrent
67457-421Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMylan Institutional LLCANDACurrent
67457-422Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMylan Institutional LLCANDACurrent
67457-423Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMylan Institutional LLCANDACurrent
67457-484Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMylan Institutional LLCANDACurrent
70518-2936Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-2936Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-3019Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-3019Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-3379Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-3379Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
71872-7147Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMedical Purchasing Solutions, LLCANDACurrent
71872-7153Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMedical Purchasing Solutions, LLCANDACurrent
71872-7157Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMedical Purchasing Solutions, LLCANDACurrent
76420-185Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAsclemed USA, Inc.ANDACurrent