Application 216274

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASICSOLUTION;INTRAVENOUS1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)NoNo
002POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASICSOLUTION;INTRAVENOUS3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)NoNo
003POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASICSOLUTION;INTRAVENOUS11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216274-001POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02
A216274-002POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02
A216274-003POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A216274-001AP
A216274-002AP
A216274-003AP

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 · 63 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A216274-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02caaa826d4ba7…
2026-08-18 06:07:402026-07A216274-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02caaa826d4ba7…
2026-08-18 06:07:402026-07A216274-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216274-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216274-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216274-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216274-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216274-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216274-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A216274-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216274-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216274-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216274-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216274-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216274-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216274-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216274-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216274-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216274-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216274-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216274-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216274-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216274-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216274-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216274-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216274-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216274-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216274-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216274-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216274-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216274-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A216274-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A216274-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216274-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216274-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216274-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216274-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216274-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216274-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216274-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-021e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A216274-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A216274-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A216274-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216274-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216274-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216274-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216274-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216274-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216274-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216274-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216274-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216274-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216274-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216274-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216274-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216274-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216274-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216274-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216274-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216274-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216274-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216274-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216274-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216274-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216274-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216274-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216274-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216274-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216274-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216274-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216274-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216274-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216274-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216274-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216274-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216274-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216274-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216274-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216274-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216274-001AP11e350fbaab3a…

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 ZIP2025-01A216274-001CGT2024-04-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216274-002CGT2024-04-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216274-003CGT2024-04-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216274-001CGT2024-04-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216274-002CGT2024-04-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216274-003CGT2024-04-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216274-001CGT2024-04-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216274-002CGT2024-04-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216274-003CGT2024-04-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216274-001CGT2024-04-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216274-002CGT2024-04-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216274-003CGT2024-04-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216274-001CGT2024-04-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A216274-002CGT2024-04-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A216274-003CGT2024-04-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216274-001CGT2024-04-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216274-002CGT2024-04-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216274-003CGT2024-04-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216274-001CGT2024-04-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216274-002CGT2024-04-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216274-003CGT2024-04-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216274-001CGT2024-04-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216274-002CGT2024-04-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216274-003CGT2024-04-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216274-001CGT2024-04-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A216274-002CGT2024-04-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A216274-003CGT2024-04-108072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216274-001CGT2024-04-136a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216274-002CGT2024-04-106a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216274-003CGT2024-04-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216274-001CGT2024-04-131c564ffb4f44…
2024-02-18 07:12 UTC2024-02A216274-002CGT2024-04-101c564ffb4f44…
2024-02-18 07:12 UTC2024-02A216274-003CGT2024-04-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216274-001CGT2024-04-13ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A216274-002CGT2024-04-10ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A216274-003CGT2024-04-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216274-001CGT2024-04-13a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216274-002CGT2024-04-10a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216274-003CGT2024-04-10a72a2bbeb626…

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
Potassium PhosphatesPOTASSIUM PHOSPHATESAmerican Regent, Inc.41a85cca-c463-4f39-9335-177b04c290a92025-02-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216274
application number: ANDA216274