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 4 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	Bryant Ranch Prepack	d416208c-474e-45c6-b28f-e86a9052edb3	2023-12-07	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	A-S Medication Solutions	44759c4f-5c87-4347-800f-83bb7487fff0	2023-12-03	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Zydus Lifesciences Limited	ca60af4c-3296-4ef9-839f-9ddb34a266da	2023-09-20		Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	a10dda0c-28fa-4678-8cea-a6ce2fce4b52	2023-09-01	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	A-S Medication Solutions	395d6d51-7093-43d5-8f18-ff5c5a8f8384	2023-08-27	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	bdfa283e-87ca-41bd-9ae1-d6652dcfa7dd	2023-07-17	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	a95020e2-9318-4a6b-8931-95771946638d	2023-07-17	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	e8086cf9-aa52-4aa5-815b-c76e8f145e0b	2023-07-17	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	896a046f-95d0-100e-e053-2a95a90aa59c	2023-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	9e500a08-0339-eb6b-e053-2a95a90a130c	2023-05-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	9e4fc2d5-985a-3734-e053-2995a90aef5b	2023-05-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	9e549ceb-00e8-64b8-e053-2a95a90aef0f	2023-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	9e545c9d-dc39-584c-e053-2995a90afda4	2023-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	9e5365a0-dd47-264a-e053-2a95a90a7fb8	2023-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	dc8b8a09-3eed-1998-e053-2995a90a2f60	2023-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	6f72b852-e741-48e5-b8e1-f8a1afcfb4d4	2023-02-01	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindacin	CLINDAMYCIN PHOSPHATE	Medimetriks Pharmaceuticals, Inc.	d01ffda3-1913-400d-a899-58b8face8936	2022-11-21	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	2e6f96d0-d928-4775-a7db-3e998fce675b	2022-04-06	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.