FDA.reportPublic FDA data

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 2 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DaptomycinDAPTOMYCINPar Health USA, LLCc1d47001-5e0f-46a3-b220-53f46b4fd6ac2025-08-19Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
daptomycinDAPTOMYCINMylan Institutional LLC95909792-972b-4c0c-b2ce-2be4bed36cff2025-08-15Warnings, Adverse reactionsName fallback
brand name: daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINHikma Pharmaceuticals USA Inc.6aa6300a-f59b-4260-b021-8a02cfaeabb72025-07-30Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINMAIA Pharmaceuticals, Inc.d87bd6b5-bf92-49c1-879b-dc2add3deae62025-07-16Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINDr.Reddy's Laboratories Inc.,7e9a1b82-f2ba-b2a4-619c-bea7768263e12025-06-30Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINQilu Pharmaceutical Co., Ltd.e32c7141-fbd9-47c8-bd1e-94b880b2c5a62025-06-16Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
daptomycinDAPTOMYCINSintetica US LLC0e55bfa7-7dbf-4fa1-8aee-eac3fe4e05e32025-02-07Warnings, Adverse reactionsName fallback
brand name: daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINXellia Pharmaceuticals USA LLC5e1f739a-eb81-43d8-9a14-89f32b7e1ba12024-05-24Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINXellia Pharmaceuticals USA LLC97c47c18-985d-4373-88f7-a86ec591ea442024-04-08Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINCivica, Inc.bcacf746-a3ee-48b5-bfbe-6a2b548ad24c2024-04-05Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINAPOTEX CORP.4bf6cd85-dfc8-44d4-b569-3ff27b9d3c092024-01-19Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINXellia Pharmaceuticals USA LLC494b2aa1-020b-432c-977e-a5d74e31e3422023-11-17Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
daptomycinDAPTOMYCINHainan Poly Pharm., Co., Ltd.6ec53f7e-9a5f-4b24-84e9-c94325750e322023-11-14Warnings, Adverse reactionsName fallback
brand name: daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINCivica, Inc.b1569dbe-7876-481e-bc1c-9c9dd85c49732023-11-13Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DAPTOMYCINDAPTOMYCINEugia US LLC353bfcaa-a0ff-47ab-829a-35ca340f6a082023-09-25Warnings, Adverse reactionsName fallback
brand name: DAPTOMYCIN
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINXellia Pharmaceuticals USA LLCfc7eef03-042b-44a1-a344-1fa8a04359002023-08-04Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINNorthStar RxLLC01f3f32a-fac1-4a8f-b205-4601046f0b5c2023-04-19Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINFresenius Kabi USA, LLCfa514937-e025-4ea7-b62a-385eb056ae702022-11-30Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN
daptomycinDAPTOMYCINSlate Run Pharmaceuticals, LLC3890474a-4425-43b3-97d4-5370cc35c2f72022-10-01Warnings, Adverse reactionsName fallback
brand name: daptomycin
generic name: DAPTOMYCIN
DaptomycinDAPTOMYCINFresenius Kabi USA, LLCa990141d-7b92-48a5-a41d-1254522e2aa12022-06-09Warnings, Adverse reactionsName fallback
brand name: Daptomycin
generic name: DAPTOMYCIN

Documents#

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