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 3 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	A-S Medication Solutions	ba3f54e5-1ff5-4ffd-8ed2-f15439f423e9	2025-11-18	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	654477df-5cbb-491a-8aec-651598b76884	2025-10-24	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Chartwell RX, LLC	7740ed35-ff93-4c5e-8983-934ff7b86da7	2025-09-05	Warnings, Adverse reactions	Name fallback 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 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 generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Alembic Pharmaceuticals Limited	41ab7061-7c3a-4a4c-9c44-16851c97ad00	2025-03-03	Warnings, Adverse reactions	Name fallback 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 generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Oceanside Pharmaceuticals	7fd5e0a2-159b-4147-947e-944eeebc1783	2024-11-11	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Solaris Pharma Corporation	fde07866-b012-47ad-932e-b76f141f86ee	2024-09-13	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Zydus Lifesciences Limited	f1f7fb55-1676-4b9e-9f2f-9eaaf33a7633	2024-08-14		Name fallback generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	51206b1e-f327-47a9-9cb3-e71f9d0c2dff	2024-08-07	Warnings, Adverse reactions	Name fallback 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 generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	00fe3546-a166-412f-a543-0ae7763c0ca0	2024-03-22	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	eddc86b8-2bcc-47ad-a11f-06e00d399a5e	2024-03-13	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	12ee0720-9979-3162-e063-6394a90a8003	2024-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	ac50088c-ba8c-4cca-a473-83011af80e85	2024-01-12	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	A-S Medication Solutions	9cf27a58-6c5f-4a02-88cc-b5ce3ecd8751	2024-01-07	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.