FDA.reportPublic FDA data

Application 204550

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEINJECTABLE;INJECTION50MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A204550-001AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2017-10-25

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A204550-001AMIODARONE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2017-10-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204550-001AMIODARONE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2017-10-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204550-001AMIODARONE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP2017-10-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204550-001AMIODARONE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2017-10-25a50c72e98297…

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 ZIP2022-06A204550-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204550-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204550-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204550-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204550-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204550-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204550-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A204550-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204550-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204550-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204550-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A204550-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204550-001AP1ea99ee380514…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204550-001AP1cb3db0bc1861…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMedical Purchasing Solutions, LLC81a15062-ba1e-37c0-e053-2991aa0af9452023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204550
application number: ANDA204550
ndc (product): 71872-7149
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAuroMedics Pharma LLC6cd870d7-6381-421a-89bc-bce5c95182192021-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204550
application number: ANDA204550
ndc (product): 55150-182
ndc (product): 55150-181
ndc (product): 55150-180

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-180Amiodarone HydrochlorideAmiodarone HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-180Amiodarone HydrochlorideAmiodarone HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-181Amiodarone HydrochlorideAmiodarone HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-181Amiodarone HydrochlorideAmiodarone HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-182Amiodarone HydrochlorideAmiodarone HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-182Amiodarone HydrochlorideAmiodarone HydrochlorideAuroMedics Pharma LLCANDACurrent
71872-7149Amiodarone HydrochlorideAmiodarone HydrochlorideMedical Purchasing Solutions, LLCANDACurrent