Application 050162

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 75MG BASE	Yes	No
002	CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 150MG BASE	Yes	No
003	CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 300MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	TE codes	RLD / RS	Approval date
N050162-001	CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982
N050162-002	CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982
N050162-003	CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N050162-001	AB
N050162-002	AB
N050162-003	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 4 · 129 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
2026-09-14 22:38:34	2026-08	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N050162-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050162-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050162-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050162-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050162-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050162-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050162-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050162-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050162-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050162-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050162-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050162-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050162-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050162-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050162-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050162-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050162-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050162-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050162-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050162-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050162-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050162-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050162-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050162-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050162-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050162-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050162-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050162-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050162-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050162-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050162-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050162-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050162-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050162-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050162-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050162-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050162-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050162-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050162-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050162-001	AB	1	`301d65b070ca…`

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 3 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	cd2ca915-5672-440d-a14e-b4d3b6a522f3	2025-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	DIRECT RX	c3f35f80-e4ae-95f5-e053-2995a90a1b64	2025-07-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	American Health Packaging	3f6b2c5a-e581-414f-bc9e-eaf66a5685cd	2025-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	12dea490-e179-f295-e063-6394a90af4aa	2025-04-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Brisk Pharmaceuticals	2de041be-1d36-ee95-e063-6294a90a2091	2025-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2178249b-a9fe-5015-e063-6294a90a9ff4	2024-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Quality Care Products, LLC	1d562ae9-5a9a-4fed-8cc7-3f30fb40f957	2024-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	7b110bab-815e-4654-860b-b9142fd93d45	2024-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2290109b-45c9-1aab-e063-6294a90a673b	2024-09-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	2b13d66d-4f48-477e-ba32-20e85d0e708d	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	7537fbab-c792-4b77-8736-c24b69cf48ea	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	8af1493c-1f22-4629-a432-f8b0578189e1	2024-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	11e8dd9c-81fd-4e88-e063-6294a90af13e	2024-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	bea7de4c-c077-4535-96a0-f6b319120b0b	2024-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	b2bd8402-c887-5bfd-e053-2a95a90a15d9	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	1d760cb7-d166-6707-e063-6394a90a8850	2024-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9e68cb17-73d9-8a00-e053-2995a90a517f	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9fe44bdd-eb59-4b55-e053-2995a90a3183	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	678912ff-a0c1-171b-e053-2991aa0ad128	2024-06-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	63f26644-b7ab-98c1-e053-2a91aa0af5d3	2024-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE

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 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0225	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0225	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0225	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0225	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0225	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0225	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0225	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0225	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0225	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0331	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0331	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0331	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0331	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0331	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0331	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0331	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0331	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0331	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0395	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0395	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0395	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0395	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0395	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0395	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0395	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0395	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0395	Cleocin Hydrochloride	clindamycin hydrochloride	Pharmacia & Upjohn Company LLC	NDA	Current
59762-3328	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3328	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3328	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3328	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3328	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3328	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3328	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3328	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3328	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5010	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5010	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5010	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5010	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5010	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5010	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5010	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5010	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5010	clindamycin hydrochloride	clindamycin hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
67296-1798	Cleocin Hydrochloride	clindamycin hydrochloride	RedPharm Drug, Inc.	NDA	Current
67296-1798	Cleocin Hydrochloride	clindamycin hydrochloride	RedPharm Drug, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85585	SUPPL	2026-03-30
85565	SUPPL	2026-03-30
85083	SUPPL	2026-02-19
85047	SUPPL	2026-02-13
79253	SUPPL	2024-07-30
79249	SUPPL	2024-07-30
71159	SUPPL	2022-05-27
71122	SUPPL	2022-05-23
62108	SUPPL	2020-03-10
62100	SUPPL	2020-03-10
59076	SUPPL	2019-06-17
59070	SUPPL	2019-06-14
53065	SUPPL	2018-03-20
53043	SUPPL	2018-03-16
48278	SUPPL	2017-05-08
48277	SUPPL	2017-05-08
48238	SUPPL	2017-05-04
48237	SUPPL	2017-05-04
17807	SUPPL	2016-03-29
17806	SUPPL	2016-03-29
29993	SUPPL	2016-03-25
7707	SUPPL	2016-03-25
38921	SUPPL	2014-06-30
38920	SUPPL	2014-06-30
29992	SUPPL	2014-06-27
7706	SUPPL	2014-06-27
7705	SUPPL	2011-06-10
7704	SUPPL	2010-01-21
17805	SUPPL	2009-11-23
29991	SUPPL	2004-10-04
17804	SUPPL	2004-10-04
7703	SUPPL	2004-02-02