Application 202493

Type: ANDA
Sponsor: MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLOROTHIAZIDE SODIUM	CHLOROTHIAZIDE SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	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
A202493-001	CHLOROTHIAZIDE SODIUM	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			2014-06-18

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	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202493-001	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-06-18	`cb3db0bc1861…`

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	A202493-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202493-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202493-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202493-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202493-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202493-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202493-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202493-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202493-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202493-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202493-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202493-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202493-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202493-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202493-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202493-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202493-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202493-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202493-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202493-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202493-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202493-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202493-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202493-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202493-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202493-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorothiazide	CHLOROTHIAZIDE SODIUM	Fresenius Kabi USA, LLC	5b5d8a97-1428-4047-8e6c-b778429a26e4	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: CHLOROTHIAZIDE SODIUM
CHLOROTHIAZIDE SODIUM	CHLOROTHIAZIDE SODIUM	Sun Pharmaceutical Industries, Inc.	187240e9-1eed-45ec-befb-18647d175112	2025-03-21	Warnings, Adverse reactions	Name fallback brand name: CHLOROTHIAZIDE SODIUM generic name: CHLOROTHIAZIDE SODIUM
Chlorothiazide	CHLOROTHIAZIDE SODIUM	Fresenius Kabi USA, LLC	de512e9b-444c-4ae4-8c6b-accd87a02021	2025-03-20	Warnings, Adverse reactions	Name fallback generic name: CHLOROTHIAZIDE SODIUM
Chlorothiazide sodium	CHLOROTHIAZIDE SODIUM	Gland Pharma Limited	bf921935-9740-458e-b786-69f76d8ad139	2024-10-07	Warnings, Adverse reactions	Name fallback brand name: Chlorothiazide sodium generic name: CHLOROTHIAZIDE SODIUM
Chlorothiazide	CHLOROTHIAZIDE SODIUM	Fresenius Kabi USA, LLC	de250776-461a-4d02-a82e-ffedca1a9cf4	2023-06-02	Warnings, Adverse reactions	Name fallback generic name: CHLOROTHIAZIDE SODIUM
Chlorothiazide Sodium	CHLOROTHIAZIDE SODIUM	American Regent, Inc.	850960a3-9fe2-4999-81eb-b0ae9ba011bc	2020-06-05	Warnings, Adverse reactions	Name fallback brand name: Chlorothiazide Sodium generic name: CHLOROTHIAZIDE SODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-263	chlorothiazide sodium	chlorothiazide sodium	Mylan Institutional LLC	ANDA	Current
67457-263	chlorothiazide sodium	chlorothiazide sodium	Mylan Institutional LLC	ANDA	Current