Application 207222

Type: ANDA
Sponsor: UMEDICA LABS PVT LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORTHALIDONE	CHLORTHALIDONE	TABLET;ORAL	25MG	No	No
002	CHLORTHALIDONE	CHLORTHALIDONE	TABLET;ORAL	50MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207222-001	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2018-05-24
A207222-002	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2018-05-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207222-001	AB
A207222-002	AB

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 3 · 82 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	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	BX	2018-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	BX	2018-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	BX	2018-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	BX	2018-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	BX	2018-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	BX	2018-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	BX	2018-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	BX	2018-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	BX	2018-05-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	BX	2018-05-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A207222-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207222-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207222-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207222-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207222-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207222-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207222-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207222-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207222-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207222-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207222-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207222-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207222-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207222-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207222-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207222-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207222-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207222-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207222-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207222-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207222-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207222-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207222-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207222-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207222-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207222-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207222-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207222-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207222-001	BX	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207222-002	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207222-001	BX	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207222-002	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207222-001	BX	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207222-002	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207222-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207222-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207222-001	BX	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207222-002	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207222-001	BX	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207222-002	BX	1	`782e0a99824c…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	bf09d68f-af7a-4057-92f1-13f1ef85d532	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222 ndc (product): 71335-0906
Chlorthalidone	CHLORTHALIDONE	Umedica Laboratories USA Inc.	645734ab-d6aa-4368-9a5a-b550e2717770	2026-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	da50019b-60ea-47b3-a355-4ab48efcbe3d	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222
Chlorthalidone	CHLORTHALIDONE	Northwind Health Company, LLC	da829c8c-ae13-510b-e053-2995a90a70b8	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222
Chlorthalidone	CHLORTHALIDONE	Northwind Health Company, LLC	df6271ff-f111-fd4a-e053-2a95a90a4b51	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222 ndc (product): 51655-961
Chlorthalidone	CHLORTHALIDONE	Nivagen Pharmaceuticals, INC.	36ef8d83-45f2-4873-b7cb-1be096d14d18	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222 ndc (product): 75834-110 ndc (product): 75834-109
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	5979af5a-0c5b-40f9-bb67-2d462e1cefb7	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	5441e163-459a-46b0-87a9-e9879091bf3c	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222 ndc (product): 63629-9298
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	ac431d1b-b307-46fe-a3a9-29f40fe6742b	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222 ndc (product): 63629-2465
Chlorthalidone	CHLORTHALIDONE	Proficient Rx LP	01337f79-4b3d-4749-a82b-8d56c1aec179	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222 ndc (product): 71205-592

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5085	Chlorthalidone	Chlorthalidone	A-S Medication Solutions	ANDA	Current
50090-5541	Chlorthalidone	Chlorthalidone	A-S Medication Solutions	ANDA	Current
50090-5541	Chlorthalidone	Chlorthalidone	A-S Medication Solutions	ANDA	Current
51655-961	Chlorthalidone	Chlorthalidone	Northwind Pharmaceuticals	ANDA	Current
63629-2465	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
63629-2465	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
63629-2465	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
63629-9298	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
68071-4636	Chlorthalidone	Chlorthalidone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4636	Chlorthalidone	Chlorthalidone	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-1376	Chlorthalidone	Chlorthalidone	REMEDYREPACK INC.	ANDA	Current
70518-1376	Chlorthalidone	Chlorthalidone	REMEDYREPACK INC.	ANDA	Current
70518-1376	Chlorthalidone	Chlorthalidone	REMEDYREPACK INC.	ANDA	Current
70518-1376	Chlorthalidone	Chlorthalidone	REMEDYREPACK INC.	ANDA	Current
70518-1376	Chlorthalidone	Chlorthalidone	REMEDYREPACK INC.	ANDA	Current
70934-470	Chlorthalidone	Chlorthalidone	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-562	Chlorthalidone	Chlorthalidone	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-592	Chlorthalidone	Chlorthalidone	Proficient Rx LP	ANDA	Current
71205-592	Chlorthalidone	Chlorthalidone	Proficient Rx LP	ANDA	Current
71335-0906	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
71335-0906	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
71335-0906	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
71335-0906	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
75834-109	Chlorthalidone	Chlorthalidone	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-109	Chlorthalidone	Chlorthalidone	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-109	Chlorthalidone	Chlorthalidone	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-109	Chlorthalidone	Chlorthalidone	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-109	Chlorthalidone	Chlorthalidone	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-110	Chlorthalidone	Chlorthalidone	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-110	Chlorthalidone	Chlorthalidone	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-110	Chlorthalidone	Chlorthalidone	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-110	Chlorthalidone	Chlorthalidone	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-110	Chlorthalidone	Chlorthalidone	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current