FDA.reportPublic FDA data

Application 076207

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAMIDRONATE DISODIUMPAMIDRONATE DISODIUMINJECTABLE;INJECTION30MG/10ML (3MG/ML)NoNo
002PAMIDRONATE DISODIUMPAMIDRONATE DISODIUMINJECTABLE;INJECTION90MG/10ML (9MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076207-001PAMIDRONATE DISODIUMPAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-17
A076207-002PAMIDRONATE DISODIUMPAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-17

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-1784e616aacf4f…
2026-09-14 22:38:342026-08A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-1784e616aacf4f…
2026-08-18 06:07:402026-07A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-17caaa826d4ba7…
2026-08-18 06:07:402026-07A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTION2002-05-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTION2002-05-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076207-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP2002-05-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076207-002PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTIONAP2002-05-1774a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076207-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076207-002AP174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A076207-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076207-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076207-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A076207-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A076207-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076207-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076207-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076207-002AP1ea99ee380514…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.9b6a9a3b-71c9-4dcb-b857-5d1de25c3a232026-05-14Warnings, Adverse reactionsName fallback
brand name: Pamidronate Disodium
generic name: PAMIDRONATE DISODIUM
Pamidronate DisodiumPAMIDRONATE DISODIUMMylan Institutional LLCc2ca033e-fa5f-4141-b702-11f8b4303da12025-12-15Warnings, Adverse reactionsName fallback
brand name: Pamidronate Disodium
generic name: PAMIDRONATE DISODIUM

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-735Pamidronate DisodiumPAMIDRONATE DISODIUMFresenius Kabi USA, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44294ORIG2008-01-07