Application 213396

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DAPTOMYCIN	DAPTOMYCIN	POWDER;INTRAVENOUS	350MG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A213396-001	DAPTOMYCIN	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS			2024-08-01

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213396-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS		2024-08-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213396-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS		2024-08-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213396-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS		2024-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213396-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS		2024-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213396-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS		2024-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213396-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS		2024-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213396-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS		2024-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213396-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2024-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213396-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2024-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213396-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2024-08-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213396-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2024-08-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213396-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2024-08-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213396-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2024-08-01	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213396-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS		2024-08-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213396-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213396-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213396-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213396-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213396-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213396-001	AP	1	`79d66fd596c7…`

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 · 46 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Daptomycin	DAPTOMYCIN	Par Health USA, LLC	c1d47001-5e0f-46a3-b220-53f46b4fd6ac	2025-08-19	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
daptomycin	DAPTOMYCIN	Mylan Institutional LLC	95909792-972b-4c0c-b2ce-2be4bed36cff	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Hikma Pharmaceuticals USA Inc.	6aa6300a-f59b-4260-b021-8a02cfaeabb7	2025-07-30	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	MAIA Pharmaceuticals, Inc.	d87bd6b5-bf92-49c1-879b-dc2add3deae6	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Dr.Reddy's Laboratories Inc.,	7e9a1b82-f2ba-b2a4-619c-bea7768263e1	2025-06-30	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Qilu Pharmaceutical Co., Ltd.	e32c7141-fbd9-47c8-bd1e-94b880b2c5a6	2025-06-16	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
daptomycin	DAPTOMYCIN	Sintetica US LLC	0e55bfa7-7dbf-4fa1-8aee-eac3fe4e05e3	2025-02-07	Warnings, Adverse reactions	Name fallback brand name: daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Xellia Pharmaceuticals USA LLC	5e1f739a-eb81-43d8-9a14-89f32b7e1ba1	2024-05-24	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Xellia Pharmaceuticals USA LLC	97c47c18-985d-4373-88f7-a86ec591ea44	2024-04-08	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Civica, Inc.	bcacf746-a3ee-48b5-bfbe-6a2b548ad24c	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	APOTEX CORP.	4bf6cd85-dfc8-44d4-b569-3ff27b9d3c09	2024-01-19	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Xellia Pharmaceuticals USA LLC	494b2aa1-020b-432c-977e-a5d74e31e342	2023-11-17	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
daptomycin	DAPTOMYCIN	Hainan Poly Pharm., Co., Ltd.	6ec53f7e-9a5f-4b24-84e9-c94325750e32	2023-11-14	Warnings, Adverse reactions	Name fallback brand name: daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Civica, Inc.	b1569dbe-7876-481e-bc1c-9c9dd85c4973	2023-11-13	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
DAPTOMYCIN	DAPTOMYCIN	Eugia US LLC	353bfcaa-a0ff-47ab-829a-35ca340f6a08	2023-09-25	Warnings, Adverse reactions	Name fallback brand name: DAPTOMYCIN generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Xellia Pharmaceuticals USA LLC	fc7eef03-042b-44a1-a344-1fa8a0435900	2023-08-04	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	NorthStar RxLLC	01f3f32a-fac1-4a8f-b205-4601046f0b5c	2023-04-19	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Fresenius Kabi USA, LLC	fa514937-e025-4ea7-b62a-385eb056ae70	2022-11-30	Warnings, Adverse reactions	Name fallback brand name: Daptomycin generic name: DAPTOMYCIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.