Application 050680

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLEOCIN	CLINDAMYCIN PHOSPHATE	CREAM;VAGINAL	EQ 2% BASE	No	No
002	CLEOCIN	CLINDAMYCIN PHOSPHATE	CREAM;VAGINAL	EQ 2% BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N050680-001	CLEOCIN	CLINDAMYCIN PHOSPHATE	EQ 2% BASE	CREAM / VAGINAL			1992-08-11
N050680-002	CLEOCIN	CLINDAMYCIN PHOSPHATE	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050680-002	AB

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 3 · 84 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
2026-08-18 06:07:40	2026-07	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050680-001	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL			1992-08-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050680-002	CLEOCIN	EQ 2% BASE	CREAM / VAGINAL	AB	RLD, RS	1998-03-02	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N050680-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050680-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050680-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050680-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050680-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050680-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050680-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050680-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050680-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050680-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050680-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050680-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050680-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050680-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050680-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050680-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050680-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050680-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050680-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050680-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050680-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050680-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050680-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050680-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050680-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050680-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050680-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050680-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050680-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050680-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050680-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050680-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050680-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050680-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050680-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050680-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050680-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050680-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050680-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050680-002	AB	1	`e64feba35796…`

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.	b52bdaf7-3b54-4165-9ab0-9dfa08170e47	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050680 application number: NDA050680 ndc (product): 59762-5009
Cleocin	CLINDAMYCIN PHOSPHATE	Pharmacia & Upjohn Company LLC	f9be442d-0782-4b93-828f-9ebbf67dbced	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050680 application number: NDA050680 ndc (product): 0009-3448

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-3448	Cleocin	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3448	Cleocin	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3448	Cleocin	clindamycin phosphate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3448	Cleocin	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3448	Cleocin	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3448	Cleocin	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3448	Cleocin	clindamycin phosphate	Pharmacia and Upjohn Company LLC	NDA	Current
59762-5009	clindamycin phosphate	clindamycin phosphate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5009	clindamycin phosphate	clindamycin phosphate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5009	clindamycin phosphate	clindamycin phosphate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5009	clindamycin phosphate	clindamycin phosphate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5009	clindamycin phosphate	clindamycin phosphate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71099	SUPPL	2022-05-19
71090	SUPPL	2022-05-18
62300	SUPPL	2020-03-24
62297	SUPPL	2020-03-24
58832	SUPPL	2019-05-22
58826	SUPPL	2019-05-22
56974	SUPPL	2018-12-21
49747	SUPPL	2017-09-15
49706	SUPPL	2017-09-11
18008	SUPPL	2015-07-16
7986	SUPPL	2015-07-15
39103	SUPPL	2014-05-12
30265	SUPPL	2014-05-12
18007	SUPPL	2003-08-29
7985	SUPPL	2003-08-29
22182	SUPPL	1998-03-02
7984	SUPPL	1998-03-02