Application 213412

Type: ANDA
Sponsor: ALKEM LABS 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 43.

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
A213412-001	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11
A213412-002	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RS	2020-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213412-001	AB
A213412-002	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 2 · 78 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
2026-09-14 22:38:34	2026-08	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RS	2020-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RS	2020-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A213412-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213412-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213412-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213412-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213412-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213412-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213412-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A213412-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213412-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A213412-002	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213412-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213412-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213412-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213412-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213412-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213412-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213412-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213412-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213412-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213412-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213412-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213412-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213412-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213412-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213412-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213412-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213412-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A213412-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213412-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213412-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213412-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213412-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213412-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A213412-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213412-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213412-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213412-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213412-002	AB	1	`a50c72e98297…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorthalidone	CHLORTHALIDONE	REMEDYREPACK INC.	7d8e26e6-7314-4799-b137-934926d343b0	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	A-S Medication Solutions	583992c2-b789-4267-9a8f-c1ee5db3f29f	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412 ndc (product): 50090-5183
Chlorthalidone	CHLORTHALIDONE	A-S Medication Solutions	7d09c992-22f7-41e1-a836-380712f242c0	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	Preferred Pharmaceuticals Inc.	d61367af-530b-4e5e-8e71-11c93f75ecf1	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	Direct_Rx	401ae38b-2eb8-c9fc-e063-6294a90af220	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	165e5993-eb9d-4664-97dc-574ae5e0e946	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	Ascend Laboratories, LLC	d104583e-e983-4230-b6d1-4455ee1060a5	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412 ndc (product): 67877-697 ndc (product): 67877-696
Chlorthalidone	CHLORTHALIDONE	Coupler LLC	2ccba8ab-4c34-af52-e063-6394a90a78d3	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	e727d42f-e4e1-4cf6-9d7a-6ec2333bc6d1	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412 ndc (product): 63629-8762
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	a1ab541b-7515-4888-b3e0-aca52875562d	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412 ndc (product): 63629-8761
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	98f4a14c-2863-4068-bd35-aaedcc872680	2023-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412 ndc (product): 71335-2072
Chlorthalidone	CHLORTHALIDONE	A-S Medication Solutions	c5796482-ad1f-437a-ae80-c288880f4100	2023-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412 ndc (product): 50090-6126

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5183	Chlorthalidone	Chlorthalidone	A-S Medication Solutions	ANDA	Current
50090-6126	Chlorthalidone	Chlorthalidone	A-S Medication Solutions	ANDA	Current
63629-8761	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
63629-8761	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
63629-8761	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
63629-8762	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
63629-8762	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
63629-8762	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
67877-696	Chlorthalidone	Chlorthalidone	Ascend Laboratories, LLC	ANDA	Current
67877-696	Chlorthalidone	Chlorthalidone	Ascend Laboratories, LLC	ANDA	Current
67877-697	Chlorthalidone	Chlorthalidone	Ascend Laboratories, LLC	ANDA	Current
67877-697	Chlorthalidone	Chlorthalidone	Ascend Laboratories, LLC	ANDA	Current
71335-2072	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
71335-2072	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current