FDA.reportPublic FDA data

Application 078151

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERBUTALINE SULFATETERBUTALINE SULFATEINJECTABLE;INJECTION1MG/MLNoNo

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

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
A078151-001TERBUTALINE SULFATETERBUTALINE SULFATE1MG/MLINJECTABLE / INJECTION2008-01-07

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A078151-001TERBUTALINE SULFATE1MG/MLINJECTABLE / INJECTION2008-01-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078151-001TERBUTALINE SULFATE1MG/MLINJECTABLE / INJECTIONAP2008-01-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078151-001TERBUTALINE SULFATE1MG/MLINJECTABLE / INJECTION2008-01-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078151-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078151-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078151-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078151-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078151-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078151-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078151-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A078151-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078151-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078151-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078151-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A078151-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078151-001AP1ea99ee380514…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078151-001AP1cb3db0bc1861…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terbutaline SulfateTERBUTALINE SULFATEChartwell RX, LLC.859267c6-3d14-4123-9b9d-4fc248f097262025-12-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Terbutaline Sulfate
generic name: TERBUTALINE SULFATE
Terbutaline SulfateTERBUTALINE SULFATEUpsher-Smith Laboratories, LLC3a4e5046-293c-4616-8679-6da65f31626b2025-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Terbutaline Sulfate
generic name: TERBUTALINE SULFATE
TERBUTALINE SULFATETERBUTALINE SULFATEAmneal Pharmaceuticals of New York LLC382dcebb-6e41-4335-818d-b5822e3fb8842025-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TERBUTALINE SULFATE
generic name: TERBUTALINE SULFATE
Terbutaline SulfateTERBUTALINE SULFATEHenry Schein, Inc.9f4b177e-4d7d-4255-afeb-522c7d4594c62025-07-16Warnings, Adverse reactionsName fallback
brand name: Terbutaline Sulfate
generic name: TERBUTALINE SULFATE
Terbutaline SulfateTERBUTALINE SULFATEHikma Pharmaceuticals USA Inc.613df3cb-4d55-4d12-ab08-a932481aaa0b2024-01-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Terbutaline Sulfate
generic name: TERBUTALINE SULFATE
Terbutaline SulfateTERBUTALINE SULFATEMedical Purchasing Solutions. LLC6a22b62c-4ee1-49df-e053-2a91aa0a3e522023-05-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Terbutaline Sulfate
generic name: TERBUTALINE SULFATE
Terbutaline SulfateTERBUTALINE SULFATEFresenius Kabi USA, LLCcec31032-f366-4524-9e01-63146e473b2b2022-07-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Terbutaline Sulfate
generic name: TERBUTALINE SULFATE
Terbutaline SulfateTERBUTALINE SULFATEProficient Rx LP0a95bc4f-34d3-4b5e-841b-6839e1c1e0c72022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Terbutaline Sulfate
generic name: TERBUTALINE SULFATE
Terbutaline SulfateTERBUTALINE SULFATELannett Company, Inc.fbf54709-5857-4dbc-9233-ebd7abff88c82020-11-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Terbutaline Sulfate
generic name: TERBUTALINE SULFATE
Terbutaline SulfateTERBUTALINE SULFATEHikma Pharmaceuticals USA Inc.0f4d3249-e022-40b6-b93d-f605e85222072020-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Terbutaline Sulfate
generic name: TERBUTALINE SULFATE
Terbutaline SulfateTERBUTALINE SULFATEANI Pharmaceuticals, Inc.d810a15b-3e10-4f6c-a36e-8ddecbaba9c32019-11-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Terbutaline Sulfate
generic name: TERBUTALINE SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-933Terbutaline SulfateTerbutaline SulfateAkornANDACurrent
17478-933Terbutaline SulfateTerbutaline SulfateAkornANDACurrent
17478-933Terbutaline SulfateTerbutaline SulfateAkornANDACurrent
17478-933Terbutaline SulfateTerbutaline SulfateAkornANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44373ORIG2011-02-17