Application 203797

Type
NDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAPTOMYCINDAPTOMYCINPOWDER;INTRAVENOUS350MG/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DaptomycinDAPTOMYCINSagent Pharmaceuticals548f3559-0531-4c95-9e1d-81f81a3801f12026-07-21Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINHospira, Inc.1957b6ce-7382-4a7b-bf02-3595948d09c62026-05-08Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINCamber Pharmaceuticals, Inc.1d29832c-564b-4694-842a-50aeeb823ec82026-04-23Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINNorthStar RxLLC3c482379-4c3c-4e94-be37-213fe0d76f192026-04-23Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINCamber Pharmaceuticals, Inc.07bc65c6-f302-4d16-9803-a8567fe76f382026-04-13Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINCivica, Inc.1ae55ae0-d20f-4e15-b4dc-7e45c33f31522026-04-09Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINHikma Pharmaceuticals USA Inc.23f39005-3008-4ab1-918d-b8acb001554e2026-03-23Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DAPTOMYCINDAPTOMYCINMeitheal Pharmaceuticals Inc.191f0224-67b7-4945-bdcd-38d60645e38c2026-03-09Warnings, Adverse reactionsName fallback
brand name: DAPTOMYCIN
generic name: DAPTOMYCIN
DAPTOMYCINDAPTOMYCINMeitheal Pharmaceuticals Inc.278ad91e-2141-4bc1-b142-a9caca65f1bf2026-02-17Warnings, Adverse reactionsName fallback
brand name: DAPTOMYCIN
generic name: DAPTOMYCIN
DAPTOMYCINDAPTOMYCINMeitheal Pharmaceuticals Inc.f5736d54-5bc2-48c6-97c6-65f7422725f02026-02-17Warnings, Adverse reactionsName fallback
brand name: DAPTOMYCIN
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINBluePoint Laboratoriesd6c3df37-8481-46c2-8048-199bad37c9332026-01-30Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINHikma Pharmaceuticals USA Inc.74176769-b22e-4e41-8c56-051e15ec5fea2025-12-18Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DAPTOMYCINDAPTOMYCINMeitheal Pharmaceuticals Inc.4f39cddc-1cb7-41d4-a657-07f7903ee24f2025-12-08Warnings, Adverse reactionsName fallback
brand name: DAPTOMYCIN
generic name: DAPTOMYCIN
daptomycinDAPTOMYCINBE Pharmaceuticals Inc.4cdf4099-db58-43b8-9fbc-afd997ccfa4b2025-10-24Warnings, Adverse reactionsName fallback
brand name: daptomycin
generic name: DAPTOMYCIN
DAPTOMYCINDAPTOMYCINAccord Healthcare Inc.956b068f-5958-49eb-9c9f-3b6e324e77d22025-10-09Warnings, Adverse reactionsName fallback
brand name: DAPTOMYCIN
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINAccord Healthcare, Inc.f69e9306-ffac-41c9-b277-a6d784f2e3412025-10-09Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DAPTOMYCINDAPTOMYCINMeitheal Pharmaceuticals Inc.7d50f20e-5e26-4cc0-ae45-830df5a46a422025-09-10Warnings, Adverse reactionsName fallback
brand name: DAPTOMYCIN
generic name: DAPTOMYCIN
daptomycinDAPTOMYCINMylan Institutional LLCb7737862-e783-4af3-9521-ae00ed7a42aa2025-09-08Warnings, Adverse reactionsName fallback
brand name: daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINBiocon Pharma Inc.914d4040-eb29-cda5-75e9-95060aa4fe6d2025-08-29Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
daptomycinDAPTOMYCINBE Pharmaceuticals Inc.c305bc9f-8aeb-40de-8492-154929764daf2025-08-29Warnings, Adverse reactionsName fallback
brand name: daptomycin
generic name: DAPTOMYCIN

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32470ORIG2015-02-19
32469ORIG2013-03-19