Application 065243

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A065243-001	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12
A065243-002	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12
A065243-003	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065243-002	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065243-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065243-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065243-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065243-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065243-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065243-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065243-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065243-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065243-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065243-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065243-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065243-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065243-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065243-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065243-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065243-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065243-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065243-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065243-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065243-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065243-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065243-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065243-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065243-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065243-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065243-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065243-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065243-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065243-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065243-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065243-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065243-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065243-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065243-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065243-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065243-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065243-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065243-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065243-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065243-002	AB	1	`6a51e52b5d6a…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Chartwell RX, LLC	e8167412-882e-4143-93c6-49e68adbcf16	2024-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065243 application number: ANDA065243

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1381	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1381	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1381	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1381	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1381	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1382	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1382	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1382	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1382	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1382	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1383	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1383	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1383	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1383	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1383	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1383	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Lannett Company, Inc.	ANDA	Current
43063-394	Clindamycin Hydrochloride	Clindamycin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-394	Clindamycin Hydrochloride	Clindamycin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-2502	Clindamycin Hydrochloride	Clindamycin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2502	Clindamycin Hydrochloride	Clindamycin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2502	Clindamycin Hydrochloride	Clindamycin Hydrochloride	A-S Medication Solutions	ANDA	Current
60760-693	Clindamycin Hydrochloride	Clindamycin Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-693	Clindamycin Hydrochloride	Clindamycin Hydrochloride	St Mary's Medical Park Pharmacy	ANDA	Current
60760-693	Clindamycin Hydrochloride	Clindamycin Hydrochloride	St Mary's Medical Park Pharmacy	ANDA	Current
60760-693	Clindamycin Hydrochloride	Clindamycin Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-829	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Direct Rx	ANDA	Current
67296-0863	Clindamycin Hydrochloride	Clindamycin Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-0863	Clindamycin Hydrochloride	Clindamycin Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-0863	Clindamycin Hydrochloride	Clindamycin Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1760	Clindamycin Hydrochloride	Clindamycin Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1760	Clindamycin Hydrochloride	Clindamycin Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68071-3045	Clindamycin Hydrochloride	Clindamycin Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-6884	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6884	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0598	Clindamycin Hydrochloride	Clindamycin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0598	Clindamycin Hydrochloride	Clindamycin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-693	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71335-0453	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0453	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0453	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0453	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1581	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1581	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72789-069	Clindamycin Hydrochloride	Clindamycin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-069	Clindamycin Hydrochloride	Clindamycin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-069	Clindamycin Hydrochloride	Clindamycin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-069	Clindamycin Hydrochloride	Clindamycin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-069	Clindamycin Hydrochloride	Clindamycin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-069	Clindamycin Hydrochloride	Clindamycin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current