Application 050441

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLEOCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	INJECTABLE;INJECTION	EQ 150MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050441-001	CLEOCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N050441-001	AP

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N050441-001	CLEOCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050441-001	CLEOCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050441-001	CLEOCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050441-001	CLEOCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N050441-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050441-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050441-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050441-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050441-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050441-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050441-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050441-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050441-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050441-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050441-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050441-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050441-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050441-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050441-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050441-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050441-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050441-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050441-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050441-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050441-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050441-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050441-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050441-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050441-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050441-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050441-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050441-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050441-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050441-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050441-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050441-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050441-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050441-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050441-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050441-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050441-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050441-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050441-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050441-001	AP	1	`3a93d1ddd44b…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Pharmacia & Upjohn Company LLC	05a75685-0af5-407c-ac57-e380c882b49d	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050441 application number: NDA050441 ndc (product): 0009-0870 ndc (product): 0009-0728 ndc (product): 0009-0902 ndc (product): 0009-0775
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Pharmacia & Upjohn Company LLC	a0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050441 application number: NDA050441 ndc (product): 0009-3051
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	ProPharma Distribution	38416189-844b-939f-e063-6394a90aa271	2025-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050441 application number: NDA050441
CLEOCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Henry Schein, Inc.	184acaee-6129-479e-850f-d89575b8b391	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050441 application number: NDA050441
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	12ee0720-9979-3162-e063-6394a90a8003	2024-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050441 application number: NDA050441
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	896a046f-95d0-100e-e053-2a95a90aa59c	2023-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050441 application number: NDA050441
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	9e549ceb-00e8-64b8-e053-2a95a90aef0f	2023-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050441 application number: NDA050441
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	9e5365a0-dd47-264a-e053-2a95a90a7fb8	2023-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050441 application number: NDA050441

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 2 · 142 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0302	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0302	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0302	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0302	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0302	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0302	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0302	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0302	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0302	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0602	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0602	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0602	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0602	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0602	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0602	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0602	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0602	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0602	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0728	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0728	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0728	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0728	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0728	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0728	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0728	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0728	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0728	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0728	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0728	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0728	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0775	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0775	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0775	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0775	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0775	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0775	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0775	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0775	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0775	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0775	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0775	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0775	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0870	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0870	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0870	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0870	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0870	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0870	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0870	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0870	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0870	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0870	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0870	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0870	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0901	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0901	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0901	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0901	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0901	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0901	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0901	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0901	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0901	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0902	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0902	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0902	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0902	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0902	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0902	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0902	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0902	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0902	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0902	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0902	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0902	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3051	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3051	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3051	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3051	Cleocin Phosphate	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3051	Cleocin Phosphate	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85586	SUPPL	2026-03-30
85563	SUPPL	2026-03-30
85068	SUPPL	2026-02-18
85039	SUPPL	2026-02-13
71132	SUPPL	2022-05-23
71124	SUPPL	2022-05-23
69503	SUPPL	2021-12-07
69491	SUPPL	2021-12-07
62052	SUPPL	2020-03-05
62046	SUPPL	2020-03-05
59134	SUPPL	2019-06-20
59131	SUPPL	2019-06-20
53715	SUPPL	2018-04-17
53701	SUPPL	2018-04-17
48280	SUPPL	2017-05-08
48279	SUPPL	2017-05-08
48240	SUPPL	2017-05-04
48239	SUPPL	2017-05-04
45028	SUPPL	2016-08-05
45027	SUPPL	2016-08-05
45004	SUPPL	2016-08-05
45003	SUPPL	2016-08-05
17827	SUPPL	2016-03-29
7741	SUPPL	2016-03-28
38938	SUPPL	2014-06-25
17826	SUPPL	2014-06-25
17825	SUPPL	2014-06-25
30022	SUPPL	2014-06-12
30021	SUPPL	2014-06-12
7740	SUPPL	2014-06-12
30020	SUPPL	2011-06-10
30019	SUPPL	2010-10-20
38937	SUPPL	2008-04-23
7739	SUPPL	2008-04-16
17824	SUPPL	2008-02-25
7738	SUPPL	2008-02-25
38935	SUPPL	2004-10-04
30016	SUPPL	2004-10-04
30018	SUPPL	2004-02-02
38936	SUPPL	2003-05-02
30017	SUPPL	2001-11-21