FDA.reportPublic FDA data

Application 214230

Type
ANDA
Sponsor
MANKIND PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUGAMMADEXSUGAMMADEXINJECTABLE;INJECTION200MG/2ML(100MG/ML)NoNo
002SUGAMMADEXSUGAMMADEXINJECTABLE;INJECTION500MG/5ML(100MG/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
A214230-001SUGAMMADEX SODIUMSUGAMMADEX SODIUMEQ 200MG BASE/2ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-28
A214230-002SUGAMMADEX SODIUMSUGAMMADEX SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A214230-001AP
A214230-002AP

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
2026-09-14 22:38:342026-08A214230-001SUGAMMADEX SODIUMEQ 200MG BASE/2ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-2884e616aacf4f…
2026-09-14 22:38:342026-08A214230-002SUGAMMADEX SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-2884e616aacf4f…
2026-08-18 06:07:402026-07A214230-001SUGAMMADEX SODIUMEQ 200MG BASE/2ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07A214230-002SUGAMMADEX SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-28caaa826d4ba7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A214230-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A214230-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A214230-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A214230-002AP1caaa826d4ba7…

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sugammadexSUGAMMADEXMedical Purchasing Solutions, LLC5b14e457-5ea1-3fe2-e063-6294a90aff6f2026-09-09Warnings, Adverse reactionsName fallback
brand name: sugammadex
generic name: SUGAMMADEX
sugammadexSUGAMMADEX SODIUMSolupharm Pharmazeutische Erzeugnisse GmbHf92c4e53-13d1-46f2-acf8-6730c3cfac692026-08-20Warnings, Adverse reactionsName fallback
brand name: sugammadex
sugammadexSUGAMMADEXAccord Healthcare Inc.57bf9b96-0550-b8e4-e063-6294a90a317b2026-08-05Warnings, Adverse reactionsName fallback
brand name: sugammadex
generic name: SUGAMMADEX
sugammadexSUGAMMADEXSomerset Therapeutics, LLC70c00636-d4ba-4939-802c-9d5a92435c932026-08-03Warnings, Adverse reactionsName fallback
brand name: sugammadex
generic name: SUGAMMADEX
sugammadexSUGAMMADEXFresenius Kabi USA, LLC8e685b67-6804-4d97-b43e-0259b3fe231f2026-08-03Warnings, Adverse reactionsName fallback
brand name: sugammadex
generic name: SUGAMMADEX
SugammadexSUGAMMADEXLupin Pharmaceuticals, Inc.9f2e66d7-a5d2-4593-bb30-6d4a418381aa2026-07-31Warnings, Adverse reactionsName fallback
brand name: Sugammadex
generic name: SUGAMMADEX
SugammadexSUGAMMADEXHikma Pharmaceuticals USA Inc.c8c1dccf-9be3-49b2-a5d9-46c2b9ca01932026-07-31Warnings, Adverse reactionsName fallback
brand name: Sugammadex
generic name: SUGAMMADEX
sugammadexSUGAMMADEXGland Pharma Limitedc61ee55a-e61b-4d3c-9ebc-cbf57290e36c2026-07-28Warnings, Adverse reactionsName fallback
brand name: sugammadex
generic name: SUGAMMADEX
SugammadexSUGAMMADEXB. Braun Medical Inc.d9d4467c-97ae-462a-9722-cc8d62db3e832026-07-28Warnings, Adverse reactionsName fallback
brand name: Sugammadex
generic name: SUGAMMADEX
sugammadexSUGAMMADEXGLENMARK PHARMACEUTICALS INC., USAe7897fc1-4553-460c-a29b-0bc91cd9ca102026-07-28Warnings, Adverse reactionsName fallback
brand name: sugammadex
generic name: SUGAMMADEX
SugammadexSUGAMMADEXNovadoz Pharmaceuticals LLCab41ea1c-266f-421c-8fc4-6e7ff518a75d2026-07-09Warnings, Adverse reactionsName fallback
brand name: Sugammadex
generic name: SUGAMMADEX
sugammadexSUGAMMADEXSun Pharmaceutical Industries, Inc.55b2eb4e-4d77-c555-e063-6294a90abf9e2026-07-03Warnings, Adverse reactionsName fallback
brand name: sugammadex
generic name: SUGAMMADEX
SugammadexSUGAMMADEXZydus Pharmaceuticals USA Inc.21028965-598b-4cfa-a614-5c28ed40306a2026-07-02Warnings, Adverse reactionsName fallback
brand name: Sugammadex
generic name: SUGAMMADEX
SugammadexSUGAMMADEXZydus Lifesciences Limitedb1ec2b5e-a571-4511-ab44-d4193441330a2026-07-02Name fallback
brand name: Sugammadex
generic name: SUGAMMADEX
SugammadexSUGAMMADEX SODIUMSagent Pharmaceuticals5b25f16e-726a-4464-88da-b188c2f4e0382026-06-16Warnings, Adverse reactionsName fallback
brand name: Sugammadex
SugammadexSUGAMMADEXCamber Pharmaceuticals, Inc.9adda802-fab2-40c1-9c2f-358debdfb2492026-05-30Warnings, Adverse reactionsName fallback
brand name: Sugammadex
generic name: SUGAMMADEX
sugammadexSUGAMMADEXFosun Pharma USA Inc.4f1c7cf8-3db7-3f92-e063-6394a90aece92026-04-03Warnings, Adverse reactionsName fallback
brand name: sugammadex
generic name: SUGAMMADEX
BRIDIONSUGAMMADEXMerck Sharp & Dohme LLC5171d883-fe8f-482c-97ab-40b00975b64a2026-03-13Warnings, Adverse reactionsName fallback
generic name: SUGAMMADEX
SugammadexSUGAMMADEXDr. Reddy's Laboratories Inc.4f90c37e-3505-0968-38fd-fc7e4dd66e822026-02-18Warnings, Adverse reactionsName fallback
brand name: Sugammadex
generic name: SUGAMMADEX
SugammadexSUGAMMADEXMylan Institutional LLCeb84def8-933b-4eba-b81f-30d40b1e3d8d2026-02-04Warnings, Adverse reactionsName fallback
brand name: Sugammadex
generic name: SUGAMMADEX

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73410ORIG 2024-02-14