Application 050648

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE	INJECTABLE;INJECTION	EQ 6MG BASE/ML	No	No
002	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE	INJECTABLE;INJECTION	EQ 12MG BASE/ML	No	No
003	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE	INJECTABLE;INJECTION	EQ 900MG BASE/100ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N050648-001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE	EQ 6MG BASE/ML	INJECTABLE / INJECTION	1989-12-29
N050648-002	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE	EQ 12MG BASE/ML	INJECTABLE / INJECTION	1989-12-29
N050648-003	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE	EQ 900MG BASE/100ML	INJECTABLE / INJECTION	1989-12-29

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N050648-001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050648-002	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050648-003	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 900MG BASE/100ML	INJECTABLE / INJECTION	1989-12-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050648-001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050648-002	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050648-003	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 900MG BASE/100ML	INJECTABLE / INJECTION	1989-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050648-001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050648-002	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050648-003	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 900MG BASE/100ML	INJECTABLE / INJECTION	1989-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050648-001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050648-002	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050648-003	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 900MG BASE/100ML	INJECTABLE / INJECTION	1989-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050648-001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050648-002	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050648-003	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 900MG BASE/100ML	INJECTABLE / INJECTION	1989-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050648-001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050648-002	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050648-003	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 900MG BASE/100ML	INJECTABLE / INJECTION	1989-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050648-001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050648-002	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050648-003	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 900MG BASE/100ML	INJECTABLE / INJECTION	1989-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050648-001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050648-002	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050648-003	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 900MG BASE/100ML	INJECTABLE / INJECTION	1989-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050648-001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050648-002	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050648-003	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 900MG BASE/100ML	INJECTABLE / INJECTION	1989-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050648-001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050648-002	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050648-003	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 900MG BASE/100ML	INJECTABLE / INJECTION	1989-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050648-001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050648-002	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050648-003	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 900MG BASE/100ML	INJECTABLE / INJECTION	1989-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050648-001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050648-002	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050648-003	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 900MG BASE/100ML	INJECTABLE / INJECTION	1989-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050648-001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050648-002	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050648-003	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 900MG BASE/100ML	INJECTABLE / INJECTION	1989-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050648-001	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	1989-12-29	`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 4 · 78 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Preferred Pharmaceuticals Inc	e06d419f-4b60-405b-9459-e01bbb8d151d	2026-03-30	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	311c05c2-a2b2-4051-b0b9-0427015aa980	2026-03-30	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Rising Pharma Holdings, Inc.	cc8262fe-8e41-49b2-97ae-7985e9a894e9	2026-03-24	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Cleocin	CLINDAMYCIN PHOSPHATE	Pharmacia & Upjohn Company LLC	3db26227-208d-4fdd-8426-1d9be5cda9b4	2026-03-09	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	5c08f86e-abd7-4717-b902-74ea336ce28a	2026-03-05	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
XACIATO	CLINDAMYCIN PHOSPHATE	Organon LLC	0423007f-28fa-4159-bf58-9174626d2347	2026-02-19	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin	CLINDAMYCIN PHOSPHATE	Henry Schein, Inc.	8a4e2ba4-90e6-48e8-a943-0c5d3f169780	2026-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	GLENMARK PHARMACEUTICALS INC., USA	d0ec3e88-40d9-4919-afc3-cf2e7e863376	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	997a23c8-f0d7-49d5-af33-e11f2ddab3c7	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	GLENMARK PHARMACEUTICALS INC., USA	d36bad26-f337-4a71-a6e5-d97b60f4e385	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
clindamycin phosphate	CLINDAMYCIN PHOSPHATE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	62a2019f-7410-4251-95ed-181925ade6e4	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Sun Pharmaceutical Industries, Inc.	80c40d1a-2541-4164-8ccb-1b512a851734	2026-01-25	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Viona Pharmaceuticals Inc	585e8b72-b350-451f-a232-199b1a01e8ce	2026-01-07	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Encube Ethicals, Inc.	ba6ae5da-affa-422b-9a53-28f3fc001523	2026-01-06	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Mylan Pharmaceuticals Inc.	f7480256-8b32-419a-8983-e2c413040dba	2025-12-12	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Alembic Pharmaceuticals Inc.	96434354-a646-4869-92a2-4052d3f7a4aa	2025-12-02	Warnings, Adverse reactions	Name fallback 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 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 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

Reported adverse events (FAERS/openFDA)#

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