Application 209478

Type: NDA
Sponsor: CMP DEV LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAROSPIR	SPIRONOLACTONE	SUSPENSION;ORAL	25MG/5ML	Yes	Yes

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
N209478-001	CAROSPIR	SPIRONOLACTONE	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N209478-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209478-001	10493083	2036-10-28		Drug product	2020-01-02
N209478-001	10624906	2036-10-28		Drug product	2020-04-27
N209478-001	10660907	2036-10-28		Drug product	2020-06-15
N209478-001	10888570	2036-10-28		Drug product	2021-01-15
N209478-001	11389461	2036-10-28		Drug product	2022-07-22
N209478-001	11395828	2036-10-28	U-2109		2022-08-02
N209478-001	11395828	2036-10-28	U-3401		2022-08-02
N209478-001	11395828	2036-10-28	U-3402		2022-08-02
N209478-001	11491166	2036-10-28		Drug product	2022-11-18
N209478-001	9757394	2036-10-28	U-2109	Drug product	2017-09-21

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`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	N209478-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209478-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209478-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209478-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209478-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209478-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209478-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209478-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209478-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209478-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209478-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209478-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209478-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209478-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209478-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209478-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209478-001	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209478-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 319 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209478-001	10493083	2036-10-28		Drug product	2020-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	10624906	2036-10-28		Drug product	2020-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	10660907	2036-10-28		Drug product	2020-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	10888570	2036-10-28		Drug product	2021-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	11389461	2036-10-28		Drug product	2022-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	11395828	2036-10-28	U-2109		2022-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	11395828	2036-10-28	U-3401		2022-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	11395828	2036-10-28	U-3402		2022-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	11491166	2036-10-28		Drug product	2022-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	9757394	2036-10-28	U-2109	Drug product	2017-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	10493083	2036-10-28		Drug product	2020-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	10624906	2036-10-28		Drug product	2020-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	10660907	2036-10-28		Drug product	2020-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	10888570	2036-10-28		Drug product	2021-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	11389461	2036-10-28		Drug product	2022-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	11395828	2036-10-28	U-2109		2022-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	11395828	2036-10-28	U-3401		2022-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	11395828	2036-10-28	U-3402		2022-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	11491166	2036-10-28		Drug product	2022-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	9757394	2036-10-28	U-2109	Drug product	2017-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209478-001	10493083	2036-10-28		Drug product	2020-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	10624906	2036-10-28		Drug product	2020-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	10660907	2036-10-28		Drug product	2020-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	10888570	2036-10-28		Drug product	2021-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	11389461	2036-10-28		Drug product	2022-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	11395828	2036-10-28	U-2109		2022-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	11395828	2036-10-28	U-3401		2022-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	11395828	2036-10-28	U-3402		2022-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	11491166	2036-10-28		Drug product	2022-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	9757394	2036-10-28	U-2109	Drug product	2017-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	10493083	2036-10-28		Drug product	2020-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	10624906	2036-10-28		Drug product	2020-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	10660907	2036-10-28		Drug product	2020-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	10888570	2036-10-28		Drug product	2021-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	11389461	2036-10-28		Drug product	2022-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	11395828	2036-10-28	U-2109		2022-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	11395828	2036-10-28	U-3401		2022-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	11395828	2036-10-28	U-3402		2022-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	11491166	2036-10-28		Drug product	2022-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	9757394	2036-10-28	U-2109	Drug product	2017-09-21	`fd3edfee7708…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPIRONOLACTONE	SPIRONOLACTONE	ATLANTIC BIOLOGICALS CORP.	122558a0-57bb-4195-9adf-d37b049cbfb5	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209478 application number: NDA209478
SPIRONOLACTONE	SPIRONOLACTONE	Padagis US LLC	522bd365-ddcc-48f4-8a98-66dc4c3bb314	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209478 application number: NDA209478
CaroSpir	CAROSPIR	CMP Pharma, Inc.	c4f70a04-7d89-4b73-8b02-17d43471bf08	2023-09-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209478 application number: NDA209478 ndc (product): 46287-020

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0120	CaroSpir	CaroSpir	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-0120	CaroSpir	CaroSpir	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-0120	CaroSpir	CaroSpir	ATLANTIC BIOLOGICALS CORP.	NDA	Current
46287-020	CaroSpir	CaroSpir	CMP Pharma, Inc.	NDA	Current
46287-020	CaroSpir	CaroSpir	CMP Pharma, Inc.	NDA	Current
46287-020	CaroSpir	CaroSpir	CMP Pharma, Inc.	NDA	Current
46287-020	CaroSpir	CaroSpir	CMP Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75316	SUPPL	2023-08-29
75294	SUPPL	2023-08-25
68559	SUPPL	2021-09-08
68557	SUPPL	2021-09-08
67961	SUPPL	2021-06-29
67928	SUPPL	2021-06-28
53642	ORIG	2018-04-10
49404	ORIG	2017-08-15
49268	ORIG	2017-08-08