Application 090108

Type: ANDA
Sponsor: SAGENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	INJECTABLE;INJECTION	EQ 150MG BASE/ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090108-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP		2011-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090108-001	AP

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 2 · 41 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	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090108-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2011-09-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A090108-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090108-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090108-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090108-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090108-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090108-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090108-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090108-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090108-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090108-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090108-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090108-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090108-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090108-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090108-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090108-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090108-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090108-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090108-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090108-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090108-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090108-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090108-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090108-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090108-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090108-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090108-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090108-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090108-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090108-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090108-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090108-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090108-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090108-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090108-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090108-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090108-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090108-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090108-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090108-001	AP	1	`cb3db0bc1861…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin	CLINDAMYCIN PHOSPHATE	Henry Schein, Inc.	8a4e2ba4-90e6-48e8-a943-0c5d3f169780	2026-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090108 application number: ANDA090108 ndc (product): 0404-9838
Clindamycin	CLINDAMYCIN PHOSPHATE	Sagent Pharmaceuticals	7a6967b3-5563-4bed-9eee-d400f800e799	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090108 application number: ANDA090108 ndc (product): 25021-115
Clindamycin	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	9e500a08-0339-eb6b-e053-2a95a90a130c	2023-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090108 application number: ANDA090108 ndc (product): 71872-7192
Clindamycin	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	9e4fc2d5-985a-3734-e053-2995a90aef5b	2023-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090108 application number: ANDA090108 ndc (product): 71872-7191
Clindamycin	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	dc8b8a09-3eed-1998-e053-2995a90a2f60	2023-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090108 application number: ANDA090108 ndc (product): 71872-7284

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9838	Clindamycin	Clindamycin Phosphate	Henry Schein, Inc.	ANDA	Current
0404-9838	Clindamycin	Clindamycin Phosphate	Henry Schein, Inc.	ANDA	Current
25021-115	Clindamycin	Clindamycin Phosphate	Sagent Pharmaceuticals	ANDA	Current
25021-115	Clindamycin	Clindamycin Phosphate	Sagent Pharmaceuticals	ANDA	Current
25021-115	Clindamycin	Clindamycin Phosphate	Sagent Pharmaceuticals	ANDA	Current
25021-115	Clindamycin	Clindamycin Phosphate	Sagent Pharmaceuticals	ANDA	Current
52584-090	Clindamycin	Clindamycin Phosphate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-090	Clindamycin	Clindamycin Phosphate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-090	Clindamycin	Clindamycin Phosphate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-090	Clindamycin	Clindamycin Phosphate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-090	Clindamycin	Clindamycin Phosphate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-090	Clindamycin	Clindamycin Phosphate	General Injectables and Vaccines, Inc.	ANDA	Current
55154-2828	Clindamycin	clindamycin phosphate	Cardinal Health	ANDA	Current
71872-7191	Clindamycin	Clindamycin Phosphate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7192	Clindamycin	Clindamycin Phosphate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7284	Clindamycin	Clindamycin Phosphate	Medical Purchasing Solutions, LLC	ANDA	Current