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 1 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	Mylan Pharmaceuticals Inc.	b52bdaf7-3b54-4165-9ab0-9dfa08170e47	2026-08-06	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Pharmacia & Upjohn Company LLC	05a75685-0af5-407c-ac57-e380c882b49d	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Sun Pharmaceutical Industries, Inc.	9dd8b4f9-9db8-4a16-abcd-bf32219e0301	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Viona Pharmaceuticals Inc	3f7a3eaa-0f10-4cbe-b035-0796413308d5	2026-07-02	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	25706fd8-d5e2-488b-9888-ee76d2686e19	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	576fbdf8-b44d-49bf-a569-601861cc402d	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindacin P	CLINDAMYCIN PHOSPHATE	Eurofarma, Inc.	288371ef-96b6-4ce3-9be1-1d9d309b400c	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	NORTHSTAR RX LLC	62e1661f-1eab-4693-8cce-c22f572baa7f	2026-06-09	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	27747e01-85eb-44de-a4a6-711a7799218a	2026-05-29	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Corporation	1a42c3b2-90b5-4a78-9f18-fa789742b033	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Company	406534a6-2234-4735-ba8f-7de4c87592e6	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Pharmacia & Upjohn Company LLC	a0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Aurobindo Pharma Limited	d4b88e7b-acac-409a-8442-010ef84f66b9	2026-04-30	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	461ab478-3cf6-4e9b-ba7d-0331b379cacf	2026-04-28	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Company	44fa506b-90ac-42de-831b-5f3f1a500fc0	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Company	78832ac6-04c5-45e0-ae4d-f56d7920dda9	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Sun Pharmaceutical Industries, Inc.	5b8a6767-2d46-401c-9f85-d427dda9eff7	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	c22fb382-afbc-4b2d-bdce-e97e21bddb23	2026-04-14	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindacin ETZ	CLINDAMYCIN PHOSPHATE	Eurofarma, Inc.	89fed26e-1cad-4c0b-8695-d6f3562ba8d5	2026-04-02	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	34f7a271-c012-6463-e063-6394a90ad1ea	2026-03-31	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.