Application 061809

Type: ANDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLEOCIN	CLINDAMYCIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 75MG BASE	No	No
002	CLEOCIN	CLINDAMYCIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 150MG BASE	No	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
A061809-001	CLEOCIN	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL		Approved before 1982
A061809-002	CLEOCIN	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		Approved before 1982

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	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A061809-001	CLEOCIN	EQ 75MG BASE	CAPSULE / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A061809-002	CLEOCIN	EQ 150MG BASE	CAPSULE / ORAL	Approved before 1982	`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 4 · 74 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	REMEDYREPACK INC.	fa084aad-07fa-44d2-8d01-d32f40acd2f3	2026-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Cardinal Health 107, LLC	b22be885-f441-473e-879a-862588dcf89d	2026-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	REMEDYREPACK INC.	7f7fc73a-86e1-4d3e-8c83-1c74621e4af4	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	HAWAII REPACK, INC.	c6703df0-b41d-439f-8e0d-d30b3039b3f8	2026-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	1dd9e6b0-bcf4-5bf4-e063-6394a90a10c2	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Major Pharmaceuticals	d53a66bf-fdbd-4a12-8d8c-4e3ab94e9ef5	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	8e3c9cf6-ab39-4fb5-94e3-232880c47700	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	de7001d1-8b83-4f8b-8e50-c07691021456	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	fadc321a-2291-4268-936f-0743fdddbe7f	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Major Pharmaceuticals	f9e6ed50-ad03-4a9e-8760-8733e04a058c	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	1dbd8448-c1e5-46df-8060-50ef82380445	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	47f76d99-2024-4531-a527-66c80deeeb37	2026-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	5f6a85c5-dca3-49b1-a029-3818a41d49bf	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	1f1b9230-b8ef-b0e4-e063-6394a90afc47	2026-06-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Unit Dose Solutions, Inc.	535e7e17-d020-4aa6-e063-6294a90ae114	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	afeb96ed-7c2e-72d3-e053-2995a90a4ed3	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	a69260bb-31b5-4f77-e053-2995a90a37e1	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	e4d91d51-b92e-4d3e-8379-f9463f450537	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Proficient Rx LP	d1aa1e91-4ac8-40d1-9fc4-963e1c9c3278	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Coupler LLC	509a9bc3-0901-0874-e063-6294a90a8816	2026-04-29	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.