Application 208083

Type: NDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	CLINDAMYCIN PHOSPHATE	SOLUTION;INTRAVENOUS	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	Yes	Yes
002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	CLINDAMYCIN PHOSPHATE	SOLUTION;INTRAVENOUS	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	Yes	Yes
003	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	CLINDAMYCIN PHOSPHATE	SOLUTION;INTRAVENOUS	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	Yes	Yes

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	RLD / RS	Approval date
N208083-001	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	CLINDAMYCIN PHOSPHATE	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20
N208083-002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	CLINDAMYCIN PHOSPHATE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20
N208083-003	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	CLINDAMYCIN PHOSPHATE	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208083-002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208083-003	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208083-001	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208083-002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208083-003	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208083-001	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208083-002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208083-003	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208083-001	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208083-002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208083-003	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208083-001	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208083-002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208083-003	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208083-001	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208083-002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208083-003	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208083-001	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208083-002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208083-003	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208083-001	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208083-002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208083-003	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208083-001	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208083-002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208083-003	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208083-001	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208083-002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208083-003	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208083-001	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208083-002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208083-003	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208083-001	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208083-002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208083-003	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208083-001	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208083-002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208083-003	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208083-001	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208083-002	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-04-20	`c0c555d07b60…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Company	44fa506b-90ac-42de-831b-5f3f1a500fc0	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208083 application number: NDA208083 ndc (product): 0338-9553 ndc (product): 0338-9545 ndc (product): 0338-9549

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 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-9545	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9545	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9545	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9545	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9545	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9545	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9545	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9545	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9545	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9549	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9549	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9549	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9549	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9549	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9549	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9549	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9549	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9549	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9553	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9553	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9553	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9553	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9553	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9553	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9553	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9553	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current
0338-9553	clindamycin phosphate	clindamycin phosphate	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72006	SUPPL	2022-09-02
72005	SUPPL	2022-09-02
72004	SUPPL	2022-09-02
71999	SUPPL	2022-09-02
71998	SUPPL	2022-09-02
71997	SUPPL	2022-09-02
66308	SUPPL	2021-02-22
66300	SUPPL	2021-02-19
59567	SUPPL	2019-08-02
59552	SUPPL	2019-08-02
48821	ORIG	2017-06-26
48080	ORIG	2017-04-21
48072	ORIG	2017-04-21