Application 065346

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	INJECTABLE;INJECTION	EQ 150MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A065346-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION			2007-03-29

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 · 44 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
2026-10-15 13:18:30	2026-09	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2007-03-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2007-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2007-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2007-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2007-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2007-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065346-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-29	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065346-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065346-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065346-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065346-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065346-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065346-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065346-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065346-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065346-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065346-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065346-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065346-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065346-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065346-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065346-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065346-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065346-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065346-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065346-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065346-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065346-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065346-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065346-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065346-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065346-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065346-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065346-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065346-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065346-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065346-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065346-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065346-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065346-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065346-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065346-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065346-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065346-001	AP	1	`cb3db0bc1861…`

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 3 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Alembic Pharmaceuticals Inc.	96434354-a646-4869-92a2-4052d3f7a4aa	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN PHOSPHATE generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	e492d645-7d2e-4f8a-a43a-9999456e9f72	2025-11-30	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	A-S Medication Solutions	c205b9e8-3f62-4176-be4e-bc4b5dbf3893	2025-11-25	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Cleocin T	CLINDAMYCIN PHOSPHATE	Pharmacia & Upjohn Company LLC	4a3901a4-194f-4a15-9c85-3d0982afcf31	2025-11-24	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Cleocin	CLINDAMYCIN PHOSPHATE	Pharmacia & Upjohn Company LLC	f9be442d-0782-4b93-828f-9ebbf67dbced	2025-11-19	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	A-S Medication Solutions	ba3f54e5-1ff5-4ffd-8ed2-f15439f423e9	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	654477df-5cbb-491a-8aec-651598b76884	2025-10-24	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Chartwell RX, LLC	7740ed35-ff93-4c5e-8983-934ff7b86da7	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	ProPharma Distribution	38416189-844b-939f-e063-6394a90aa271	2025-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	NORTHSTAR RX LLC	f8c7339a-5180-4c6a-99bf-8a7e4d94f2d2	2025-07-09	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Sun Pharmaceutical Industries, Inc.	20333796-e2b9-4e11-860b-1dc5ff038b03	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Alembic Pharmaceuticals Limited	41ab7061-7c3a-4a4c-9c44-16851c97ad00	2025-03-03	Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN PHOSPHATE generic name: CLINDAMYCIN PHOSPHATE
CLEOCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Henry Schein, Inc.	184acaee-6129-479e-850f-d89575b8b391	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindesse	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	fe8bb204-f173-44fe-803b-b08f2ec5aa31	2025-01-30	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Solaris Pharma Corporation	b46941a9-e75f-48f7-b426-03f307499713	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Oceanside Pharmaceuticals	7fd5e0a2-159b-4147-947e-944eeebc1783	2024-11-11	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Solaris Pharma Corporation	fde07866-b012-47ad-932e-b76f141f86ee	2024-09-13	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Zydus Lifesciences Limited	f1f7fb55-1676-4b9e-9f2f-9eaaf33a7633	2024-08-14		Name fallback brand name: Clindamycin phosphate generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	51206b1e-f327-47a9-9cb3-e71f9d0c2dff	2024-08-07	Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN PHOSPHATE generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Amneal Pharmaceuticals NY LLC	ea1d4a37-7da2-4228-8451-6367e1a62554	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-282	Clindamycin	CLINDAMYCIN PHOSPHATE	Fresenius Kabi USA, LLC	ANDA	Current