Application 212121

Type
NDA
Sponsor
CMP DEV LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASICSOLUTION;INTRAVENOUS4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)YesYes

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
N212121-001POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD2019-09-19

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N212121-001106321502039-04-19U-2789Drug product2020-05-04

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 UTC2026-02N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD2019-09-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD2019-09-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD2019-09-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD2019-09-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD2019-09-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD2019-09-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD2019-09-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD2019-09-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N212121-001POTASSIUM PHOSPHATES4500MG/15ML (300MG/ML);2650MG/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-193f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-193f0d92c62455…
2023-05-13 08:27 UTC2023-05N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-19053a50430f4f…
2023-01-26 05:58 UTC2023-01N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-09-19cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N212121-001POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)SOLUTION / INTRAVENOUSRLD2019-09-19a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N212121-001106321502039-04-19U-2789Drug product2020-05-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212121-001106321502039-04-19U-2789Drug product2020-05-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N212121-001106321502039-04-19U-2789Drug product2020-05-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212121-001106321502039-04-19U-2789Drug product2020-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212121-001106321502039-04-19U-2789Drug product2020-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212121-001106321502039-04-19U-2789Drug product2020-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212121-001106321502039-04-19U-2789Drug product2020-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212121-001106321502039-04-19U-2789Drug product2020-05-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212121-001106321502039-04-19U-2789Drug product2020-05-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N212121-001106321502039-04-19U-2789Drug product2020-05-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212121-001106321502039-04-19U-2789Drug product2020-05-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212121-001106321502039-04-19U-2789Drug product2020-05-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212121-001106321502039-04-19U-2789Drug product2020-05-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N212121-001106321502039-04-19U-2789Drug product2020-05-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N212121-001106321502039-04-19U-2789Drug product2020-05-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N212121-001106321502039-04-19U-2789Drug product2020-05-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N212121-001106321502039-04-19U-2789Drug product2020-05-044b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N212121-001106321502039-04-19U-2789Drug product2020-05-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N212121-001106321502039-04-19U-2789Drug product2020-05-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N212121-001106321502039-04-19U-2789Drug product2020-05-0487673890dc5c…
2021-03-12 10:30 UTC2021-03N212121-001106321502039-04-19U-2789Drug product2020-05-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N212121-001106321502039-04-19U-2789Drug product2020-05-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11N212121-001106321502039-04-19U-2789Drug product2020-05-04c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N212121-001106321502039-04-19U-2789Drug product2020-05-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N212121-001106321502039-04-19U-2789Drug product2020-05-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12N212121-001106321502039-04-19U-2789Drug product2020-05-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N212121-001106321502039-04-19U-2789Drug product2020-05-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N212121-001106321502039-04-19U-2789Drug product2020-05-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N212121-001106321502039-04-19U-2789Drug product2020-05-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N212121-001106321502039-04-19U-2789Drug product2020-05-043f0d92c62455…
2023-05-13 08:27 UTC2023-05N212121-001106321502039-04-19U-2789Drug product2020-05-04053a50430f4f…
2023-01-26 05:58 UTC2023-01N212121-001106321502039-04-19U-2789Drug product2020-05-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N212121-001106321502039-04-19U-2789Drug product2020-05-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N212121-001106321502039-04-19U-2789Drug product2020-05-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N212121-001106321502039-04-19U-2789Drug product2020-05-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N212121-001106321502039-04-19U-2789Drug product2020-05-04cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N212121-001106321502039-04-19U-2789Drug product2020-05-04a50c72e98297…

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
Potassium PhosphatesPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASICCIVICA, INC.f7702b2f-d0d1-4696-896d-571607fc0dc82026-07-10Warnings, Adverse reactionsName fallback
brand name: Potassium Phosphates
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATESGLENMARK PHARMACEUTICALS INC., USA70c7710c-a354-4941-bd46-e64d6ea6b5dc2026-03-20Warnings, Adverse reactionsName fallback
brand name: POTASSIUM PHOSPHATES
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATESCaplin Steriles Limitedfbbd8380-9848-4862-8c73-2f53fcdf71202026-03-16Warnings, Adverse reactionsName fallback
brand name: POTASSIUM PHOSPHATES
Potassium PhosphatesPOTASSIUM PHOSPHATESHospira, Inc.2fcbc814-c7a4-469a-8b1d-6819b961bfb92025-09-30Warnings, Adverse reactionsName fallback
brand name: Potassium Phosphates
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATES IN SODIUM CHLORIDEAmneal Pharmaceuticals LLCdce22c93-aa48-48a9-ac8b-716400d33c9e2025-09-01Warnings, Adverse reactionsName fallback
brand name: POTASSIUM PHOSPHATES
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,Amneal Pharmaceuticals Private Limited125121b8-bc4c-44ee-906e-e72f652a5aa62025-04-30Warnings, Adverse reactionsName fallback
brand name: POTASSIUM PHOSPHATES
Potassium PhosphatesPOTASSIUM PHOSPHATESFresenius Kabi USA, LLC357c3020-ea6f-4401-a2e7-cebb82b031442025-04-15Warnings, Adverse reactionsName fallback
brand name: Potassium Phosphates
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,Amneal Pharmaceuticals Private Limited98315c6e-308d-423b-a046-4be1f54d30ae2025-04-14Warnings, Adverse reactionsName fallback
brand name: POTASSIUM PHOSPHATES
Potassium PhosphatesPOTASSIUM PHOSPHATESCipla USA Inc.f1f26a17-d2e2-48f5-9054-8ee7e380556e2025-02-28Warnings, Adverse reactionsName fallback
brand name: Potassium Phosphates
Potassium PhosphatesPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASICFresenius Kabi USA, LLC475f5cd7-45bd-412a-b419-9962585d6cda2025-02-28Warnings, Adverse reactionsName fallback
brand name: Potassium Phosphates
Potassium PhosphatesPOTASSIUM PHOSPHATESAmerican Regent, Inc.41a85cca-c463-4f39-9335-177b04c290a92025-02-07Warnings, Adverse reactionsName fallback
brand name: Potassium Phosphates
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,Amneal Pharmaceuticals Private Limited89136c51-a60b-4269-bd05-9489f060a7342024-12-31Warnings, Adverse reactionsName fallback
brand name: POTASSIUM PHOSPHATES

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46287-024POTASSIUM PHOSPHATESmonobasic potassium phosphate and dibasic potassium phosphateCMP PHARMA, INC.NDACurrent
46287-024POTASSIUM PHOSPHATESmonobasic potassium phosphate and dibasic potassium phosphateCMP PHARMA, INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62809ORIG2020-05-04
60082ORIG2019-09-20
60081ORIG2019-09-20