Home Applications 210282 Application 210282
Type NDA
Sponsor HOSPIRA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS, SUBCUTANEOUS 350MG/VIAL Yes No 002 DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS, SUBCUTANEOUS 500MG/VIAL Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210282-001 DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 N210282-002 DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210282-001 10357535 2033-09-11 U-3176 Drug product 2021-07-20 N210282-001 9655946 2033-09-11 U-3175 Drug product 2021-07-20 N210282-002 10357535 2033-09-11 U-3176 Drug product 2021-07-20 N210282-002 9655946 2033-09-11 U-3175 Drug product 2021-07-20
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 1 of 2 · 66 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210282-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210282-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-21 6a51e52b5d6a…
Observed Orange Book patent history# Patent history page 1 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210282-001 10357535 2033-09-11 U-3176 Drug product 2021-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210282-001 9655946 2033-09-11 U-3175 Drug product 2021-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210282-002 10357535 2033-09-11 U-3176 Drug product 2021-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210282-002 9655946 2033-09-11 U-3175 Drug product 2021-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210282-001 10357535 2033-09-11 U-3176 Drug product 2021-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210282-001 9655946 2033-09-11 U-3175 Drug product 2021-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210282-002 10357535 2033-09-11 U-3176 Drug product 2021-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210282-002 9655946 2033-09-11 U-3175 Drug product 2021-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210282-001 10357535 2033-09-11 U-3176 Drug product 2021-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210282-001 9655946 2033-09-11 U-3175 Drug product 2021-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210282-002 10357535 2033-09-11 U-3176 Drug product 2021-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210282-002 9655946 2033-09-11 U-3175 Drug product 2021-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210282-001 10357535 2033-09-11 U-3176 Drug product 2021-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210282-001 9655946 2033-09-11 U-3175 Drug product 2021-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210282-002 10357535 2033-09-11 U-3176 Drug product 2021-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210282-002 9655946 2033-09-11 U-3175 Drug product 2021-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210282-001 10357535 2033-09-11 U-3176 Drug product 2021-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210282-001 9655946 2033-09-11 U-3175 Drug product 2021-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210282-002 10357535 2033-09-11 U-3176 Drug product 2021-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210282-002 9655946 2033-09-11 U-3175 Drug product 2021-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210282-001 10357535 2033-09-11 U-3176 Drug product 2021-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210282-001 9655946 2033-09-11 U-3175 Drug product 2021-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210282-002 10357535 2033-09-11 U-3176 Drug product 2021-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210282-002 9655946 2033-09-11 U-3175 Drug product 2021-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210282-001 10357535 2033-09-11 U-3176 Drug product 2021-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210282-001 9655946 2033-09-11 U-3175 Drug product 2021-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210282-002 10357535 2033-09-11 U-3176 Drug product 2021-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210282-002 9655946 2033-09-11 U-3175 Drug product 2021-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210282-001 10357535 2033-09-11 U-3176 Drug product 2021-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210282-001 9655946 2033-09-11 U-3175 Drug product 2021-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210282-002 10357535 2033-09-11 U-3176 Drug product 2021-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210282-002 9655946 2033-09-11 U-3175 Drug product 2021-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210282-001 10357535 2033-09-11 U-3176 Drug product 2021-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210282-001 9655946 2033-09-11 U-3175 Drug product 2021-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210282-002 10357535 2033-09-11 U-3176 Drug product 2021-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210282-002 9655946 2033-09-11 U-3175 Drug product 2021-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210282-001 10357535 2033-09-11 U-3176 Drug product 2021-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210282-001 9655946 2033-09-11 U-3175 Drug product 2021-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210282-002 10357535 2033-09-11 U-3176 Drug product 2021-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210282-002 9655946 2033-09-11 U-3175 Drug product 2021-07-20 d06236e962d9…
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0409-0120 Daptomycin DAPTOMYCIN Hospira, Inc. NDA Current 0409-0120 Daptomycin DAPTOMYCIN Hospira, Inc. NDA Current 0409-0120 Daptomycin DAPTOMYCIN Hospira, Inc. NDA Current 0409-0122 Daptomycin DAPTOMYCIN Hospira, Inc. NDA Current 0409-0122 Daptomycin DAPTOMYCIN Hospira, Inc. NDA Current 0409-0122 Daptomycin DAPTOMYCIN Hospira, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 82145 SUPPL 2025-05-05 82290 SUPPL 2025-04-30 71756 SUPPL 2022-08-09 71749 SUPPL 2022-08-08 71053 ORIG 2022-05-12 67886 ORIG 2021-06-24 67869 ORIG 2021-06-23