Application 050537

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLEOCIN T	CLINDAMYCIN PHOSPHATE	SOLUTION;TOPICAL	EQ 1% BASE	Yes	Yes
002	CLEOCIN	CLINDAMYCIN PHOSPHATE	SWAB;TOPICAL	EQ 1% BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050537-001	CLEOCIN T	CLINDAMYCIN PHOSPHATE	EQ 1% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982
N050537-002	CLEOCIN	CLINDAMYCIN PHOSPHATE	EQ 1% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SWAB / TOPICAL		RLD	1994-02-22

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050537-001	CLEOCIN T	EQ 1% BASE	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL	AT	RLD	1994-02-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050537-001	CLEOCIN T	EQ 1% BASE	SOLUTION / TOPICAL		RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL		RLD	1994-02-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050537-001	CLEOCIN T	EQ 1% BASE	SOLUTION / TOPICAL		RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL		RLD	1994-02-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050537-001	CLEOCIN T	EQ 1% BASE	SOLUTION / TOPICAL		RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL		RLD	1994-02-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050537-001	CLEOCIN T	EQ 1% BASE	SOLUTION / TOPICAL		RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL	AT	RLD, RS	1994-02-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050537-001	CLEOCIN T	EQ 1% BASE	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL	AT	RLD, RS	1994-02-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050537-001	CLEOCIN T	EQ 1% BASE	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL	AT	RLD, RS	1994-02-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050537-001	CLEOCIN T	EQ 1% BASE	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL	AT	RLD	1994-02-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050537-001	CLEOCIN T	EQ 1% BASE	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL	AT	RLD	1994-02-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050537-001	CLEOCIN T	EQ 1% BASE	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL	AT	RLD	1994-02-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050537-001	CLEOCIN T	EQ 1% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL		RLD	1994-02-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050537-001	CLEOCIN T	EQ 1% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL		RLD	1994-02-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050537-001	CLEOCIN T	EQ 1% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL		RLD	1994-02-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050537-001	CLEOCIN T	EQ 1% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL		RLD	1994-02-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050537-001	CLEOCIN T	EQ 1% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL		RLD	1994-02-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050537-001	CLEOCIN T	EQ 1% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL		RLD	1994-02-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050537-001	CLEOCIN T	EQ 1% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL		RLD	1994-02-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050537-001	CLEOCIN T	EQ 1% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL		RLD	1994-02-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050537-001	CLEOCIN T	EQ 1% BASE	SOLUTION / TOPICAL		RLD, Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL		RLD	1994-02-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050537-001	CLEOCIN T	EQ 1% BASE	SOLUTION / TOPICAL		RLD, Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050537-002	CLEOCIN	EQ 1% BASE	SWAB / TOPICAL		RLD	1994-02-22	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050537-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050537-002	AT	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	N050537-002	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050537-001	AT	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050537-002	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050537-001	AT	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050537-002	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050537-001	AT	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050537-002	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050537-001	AT	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050537-002	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050537-001	AT	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050537-002	AT	1	`ea99ee380514…`

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 · 2 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.	f7480256-8b32-419a-8983-e2c413040dba	2025-12-12	Warnings, Adverse reactions	Exact identifier ndc (product): 59762-3728
Cleocin T	CLINDAMYCIN PHOSPHATE	Pharmacia & Upjohn Company LLC	4a3901a4-194f-4a15-9c85-3d0982afcf31	2025-11-24	Warnings, Adverse reactions	Exact identifier ndc (product): 0009-3116

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-3116	Cleocin T	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3116	Cleocin T	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3116	Cleocin T	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3116	Cleocin T	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3116	Cleocin T	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
59762-3728	clindamycin phosphate	clindamycin phosphate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3728	clindamycin phosphate	clindamycin phosphate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3728	clindamycin phosphate	clindamycin phosphate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3728	clindamycin phosphate	clindamycin phosphate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84160	SUPPL	2025-11-13
84148	SUPPL	2025-11-13
61335	SUPPL	2019-12-19
61319	SUPPL	2019-12-17
58704	SUPPL	2019-05-15
58387	SUPPL	2019-04-24
50451	SUPPL	2017-11-17
50439	SUPPL	2017-11-17
17860	SUPPL	2016-01-26
30061	SUPPL	2016-01-20
17859	SUPPL	2014-04-08
7796	SUPPL	2014-04-07
17858	SUPPL	2003-06-08
7795	SUPPL	2003-06-08
30060	SUPPL	2002-07-14
17857	SUPPL	2002-07-14