Application 203513

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	CLINDAMYCIN PALMITATE HYDROCHLORIDE	FOR SOLUTION;ORAL	EQ 75MG BASE/5ML	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
A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL			2014-03-13

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	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203513-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203513-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203513-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203513-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203513-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203513-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203513-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203513-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203513-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203513-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203513-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203513-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203513-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203513-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203513-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203513-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203513-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203513-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203513-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203513-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203513-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203513-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203513-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203513-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203513-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203513-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203513-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203513-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203513-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203513-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203513-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203513-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203513-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203513-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203513-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203513-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203513-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203513-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203513-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203513-001	AA	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Palmitate Hydrochloride (Pediatric)	CLINDAMYCIN PALMITATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	faf67eb8-1fd7-4b2c-a55b-24ba664c0dce	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203513 application number: ANDA203513
Clindamycin Palmitate Hydrochloride (Pediatric)	CLINDAMYCIN PALMITATE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	a85e28ea-03be-471f-ad7f-f5c55c67ac97	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203513 application number: ANDA203513 ndc (product): 65162-468

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-569	Clindamycin Palmitate Hydrochloride	Clindamycin Palmitate Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-569	Clindamycin Palmitate Hydrochloride	Clindamycin Palmitate Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
65162-468	Clindamycin Palmitate Hydrochloride	Clindamycin Palmitate Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-468	Clindamycin Palmitate Hydrochloride	Clindamycin Palmitate Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-468	Clindamycin Palmitate Hydrochloride	Clindamycin Palmitate Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-468	Clindamycin Palmitate Hydrochloride	Clindamycin Palmitate Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-468	Clindamycin Palmitate Hydrochloride	Clindamycin Palmitate Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-468	Clindamycin Palmitate Hydrochloride	Clindamycin Palmitate Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current