Application 202857

Type: ANDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DAPTOMYCIN	DAPTOMYCIN	POWDER;INTRAVENOUS	500MG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202857-001	DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS			2014-09-12

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2014-09-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2014-09-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2014-09-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2014-09-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2014-09-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2014-09-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2014-09-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2014-09-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202857-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2014-09-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A202857-001	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202857-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202857-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202857-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202857-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202857-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202857-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202857-001	AP	1	`ea99ee380514…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daptomycin	DAPTOMYCIN	Sagent Pharmaceuticals	548f3559-0531-4c95-9e1d-81f81a3801f1	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Hospira, Inc.	1957b6ce-7382-4a7b-bf02-3595948d09c6	2026-05-08	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Camber Pharmaceuticals, Inc.	1d29832c-564b-4694-842a-50aeeb823ec8	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	NorthStar RxLLC	3c482379-4c3c-4e94-be37-213fe0d76f19	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Camber Pharmaceuticals, Inc.	07bc65c6-f302-4d16-9803-a8567fe76f38	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Civica, Inc.	1ae55ae0-d20f-4e15-b4dc-7e45c33f3152	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Hikma Pharmaceuticals USA Inc.	23f39005-3008-4ab1-918d-b8acb001554e	2026-03-23	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
DAPTOMYCIN	DAPTOMYCIN	Meitheal Pharmaceuticals Inc.	191f0224-67b7-4945-bdcd-38d60645e38c	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: DAPTOMYCIN generic name: DAPTOMYCIN
DAPTOMYCIN	DAPTOMYCIN	Meitheal Pharmaceuticals Inc.	278ad91e-2141-4bc1-b142-a9caca65f1bf	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: DAPTOMYCIN generic name: DAPTOMYCIN
DAPTOMYCIN	DAPTOMYCIN	Meitheal Pharmaceuticals Inc.	f5736d54-5bc2-48c6-97c6-65f7422725f0	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: DAPTOMYCIN generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	BluePoint Laboratories	d6c3df37-8481-46c2-8048-199bad37c933	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Hikma Pharmaceuticals USA Inc.	74176769-b22e-4e41-8c56-051e15ec5fea	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
DAPTOMYCIN	DAPTOMYCIN	Meitheal Pharmaceuticals Inc.	4f39cddc-1cb7-41d4-a657-07f7903ee24f	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: DAPTOMYCIN generic name: DAPTOMYCIN
daptomycin	DAPTOMYCIN	BE Pharmaceuticals Inc.	4cdf4099-db58-43b8-9fbc-afd997ccfa4b	2025-10-24	Warnings, Adverse reactions	Name fallback brand name: daptomycin generic name: DAPTOMYCIN
DAPTOMYCIN	DAPTOMYCIN	Accord Healthcare Inc.	956b068f-5958-49eb-9c9f-3b6e324e77d2	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: DAPTOMYCIN generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Accord Healthcare, Inc.	f69e9306-ffac-41c9-b277-a6d784f2e341	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
DAPTOMYCIN	DAPTOMYCIN	Meitheal Pharmaceuticals Inc.	7d50f20e-5e26-4cc0-ae45-830df5a46a42	2025-09-10	Warnings, Adverse reactions	Name fallback brand name: DAPTOMYCIN generic name: DAPTOMYCIN
daptomycin	DAPTOMYCIN	Mylan Institutional LLC	b7737862-e783-4af3-9521-ae00ed7a42aa	2025-09-08	Warnings, Adverse reactions	Name fallback brand name: daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Biocon Pharma Inc.	914d4040-eb29-cda5-75e9-95060aa4fe6d	2025-08-29	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
daptomycin	DAPTOMYCIN	BE Pharmaceuticals Inc.	c305bc9f-8aeb-40de-8492-154929764daf	2025-08-29	Warnings, Adverse reactions	Name fallback brand name: daptomycin generic name: DAPTOMYCIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-0106	Daptomycin	DAPTOMYCIN	Hospira, Inc.	ANDA	Current
0409-0106	Daptomycin	DAPTOMYCIN	Hospira, Inc.	ANDA	Current
0409-0106	Daptomycin	DAPTOMYCIN	Hospira, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10123	ORIG	2014-09-16