Application 011145

Type: NDA
Sponsor: OAK PHARMS AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	DIURIL	CHLOROTHIAZIDE	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	DIURIL	CHLOROTHIAZIDE	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	DIURIL	CHLOROTHIAZIDE SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS
N011145-002	DIURIL	CHLOROTHIAZIDE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N011145-004	DIURIL	CHLOROTHIAZIDE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N011145-005	DIURIL	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011145-004	DIURIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011145-005	DIURIL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011145-002	DIURIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011145-004	DIURIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011145-005	DIURIL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011145-002	DIURIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011145-004	DIURIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011145-005	DIURIL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011145-002	DIURIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N011145-004	DIURIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N011145-005	DIURIL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011145-002	DIURIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011145-004	DIURIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011145-005	DIURIL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011145-002	DIURIL	500MG	TABLET / ORAL		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N011145-004	DIURIL	250MG	TABLET / ORAL		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N011145-005	DIURIL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011145-002	DIURIL	500MG	TABLET / ORAL		RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N011145-004	DIURIL	250MG	TABLET / ORAL		RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N011145-005	DIURIL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011145-002	DIURIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011145-004	DIURIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011145-005	DIURIL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011145-002	DIURIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N011145-004	DIURIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N011145-005	DIURIL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011145-002	DIURIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N011145-004	DIURIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N011145-005	DIURIL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011145-002	DIURIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011145-004	DIURIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011145-005	DIURIL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N011145-002	DIURIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N011145-004	DIURIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N011145-005	DIURIL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N011145-002	DIURIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N011145-004	DIURIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N011145-005	DIURIL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N011145-002	DIURIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N011145-004	DIURIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011145-005	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011145-005	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011145-005	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011145-005	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011145-005	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011145-005	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011145-005	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N011145-005	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N011145-005	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N011145-005	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N011145-005	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N011145-005	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N011145-005	AP	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N011145-005	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N011145-005	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N011145-005	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N011145-005	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N011145-005	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N011145-005	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N011145-005	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N011145-005	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N011145-005	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N011145-005	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N011145-005	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIURIL	CHLOROTHIAZIDE	Salix Pharmaceuticals, Inc	bd936e35-1af8-42da-bcc0-f22489d68574	2021-11-01	Warnings, Adverse reactions	Name fallback brand name: DIURIL generic name: CHLOROTHIAZIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-419	Chlorothiazide Sodium	Chlorothiazide Sodium	Akorn, Inc.	NDA AUTHORIZED GENERIC	Current
17478-419	Chlorothiazide Sodium	Chlorothiazide Sodium	Akorn	NDA AUTHORIZED GENERIC	Current
17478-419	Chlorothiazide Sodium	Chlorothiazide Sodium	Akorn	NDA AUTHORIZED GENERIC	Current
17478-419	Chlorothiazide Sodium	Chlorothiazide Sodium	Akorn, Inc.	NDA AUTHORIZED GENERIC	Current
17478-419	Chlorothiazide Sodium	Chlorothiazide Sodium	Akorn, Inc.	NDA AUTHORIZED GENERIC	Current
76478-711	Sodium Diuril	chlorothiazide sodium	Akorn	NDA	Current
76478-711	Sodium Diuril	chlorothiazide sodium	Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)	NDA	Current
76478-711	Sodium Diuril	chlorothiazide sodium	Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)	NDA	Current
76478-711	Sodium Diuril	chlorothiazide sodium	Akorn	NDA	Current
76478-711	Sodium Diuril	chlorothiazide sodium	Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
252	SUPPL	2005-08-11
251	SUPPL	2004-10-29
11922	SUPPL	2004-09-29
250	SUPPL	2004-09-29