Application 090747

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATEBETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATEINJECTABLE;INJECTION3MG/ML;EQ 3MG BASE/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
A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATEBETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090747-001AB

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 UTC2026-02A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31cb3db0bc1861…

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 UTC2026-02A090747-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090747-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090747-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090747-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090747-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090747-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090747-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090747-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090747-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090747-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090747-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090747-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090747-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090747-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090747-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090747-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090747-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090747-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090747-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090747-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090747-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090747-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090747-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090747-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090747-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090747-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090747-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090747-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090747-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090747-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090747-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090747-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090747-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090747-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090747-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090747-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090747-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090747-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090747-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090747-001AB1cb3db0bc1861…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betamethasone Sodium Phosphate and Betamethasone AcetateBETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATEAmerican Regent, Inc.335f17e7-069d-456c-8507-26253692f2ee2025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090747
application number: ANDA090747
ndc (product): 0517-0791
Betamethasone Sodium Phosphate and Betamethasone AcetateBETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATEAmerican Regent, Inc.be3e57df-339a-4b7c-9528-d478af8c78552025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090747
application number: ANDA090747
ndc (product): 0517-0799
Betamethasone Sodium Phosphate and Betamethasone AcetateBETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATEAmerican Regent, Inc.a363b861-4873-465e-8009-0e96906662242024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090747
application number: ANDA090747
ndc (product): 0517-0720
Betamethasone Sodium Phosphate and Betamethasone AcetateBETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATEAsclemed USA, Inc.c0a09d83-2405-450b-9f35-803d128232132022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090747
application number: ANDA090747
ndc (product): 76420-007

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-0720Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
0517-0720Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
0517-0720Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
0517-0720Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
0517-0791Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
0517-0791Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
0517-0799Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
0517-0799Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
40042-048Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetatePharmaForce, Inc.ANDACurrent
53225-3665ReadySharp BetamethasoneBetamethasone Sodium Phosphate and Betamethasone AcetateTerrain PharmaceuticalsANDACurrent
53225-3665ReadySharp BetamethasoneBetamethasone Sodium Phosphate and Betamethasone AcetateTerrain PharmaceuticalsANDACurrent
53225-3665ReadySharp BetamethasoneBetamethasone Sodium Phosphate and Betamethasone AcetateTerrain PharmaceuticalsANDACurrent
53225-3665ReadySharp BetamethasoneBetamethasone Sodium Phosphate and Betamethasone AcetateTerrain PharmaceuticalsANDACurrent
68788-7327ReadySharp BetamethasoneBetamethasone Sodium Phosphate and Betamethasone AcetatePreferred Pharmaceuticals Inc.ANDACurrent
69263-805BSP 0820Betamethasone Sodium Phosphate, Betamethasone AcetateOaklock, LLCANDACurrent
69263-805BSP 0820Betamethasone Sodium Phosphate, Betamethasone AcetateOaklock, LLCANDACurrent
69263-822Beta 1 KitBetamethasone Sodium Phosphate, Betamethasone AcetateOaklock, LLCANDACurrent
69263-822Beta 1 KitBetamethasone Sodium Phosphate, Betamethasone AcetateOaklock, LLCANDACurrent
69263-822Beta 1 KitBetamethasone Sodium Phosphate, Betamethasone AcetateOaklock, LLCANDACurrent
69263-822Beta 1 KitBetamethasone Sodium Phosphate, Betamethasone AcetateOaklock, LLCANDACurrent
70518-0506Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateREMEDYREPACK INC.ANDACurrent
70518-0506Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateREMEDYREPACK INC.ANDACurrent
70518-0506Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateREMEDYREPACK INC.ANDACurrent
76420-007Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAsclemed USA, Inc.ANDACurrent
76420-007Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAsclemed USA, Inc.ANDACurrent