Application 086831

Type: ANDA
Sponsor: MYLAN

Application Products#

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

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

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
A086831-001	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
A086831-002	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086831-001	AB
A086831-002	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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A086831-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A086831-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A086831-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A086831-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A086831-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A086831-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086831-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086831-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086831-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086831-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086831-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086831-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086831-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086831-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086831-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086831-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086831-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086831-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086831-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086831-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086831-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086831-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086831-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086831-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086831-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086831-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086831-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086831-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086831-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086831-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086831-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086831-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086831-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086831-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086831-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086831-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086831-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086831-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086831-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086831-002	AB	1	`4b0b4de00fa7…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorthalidone	CHLORTHALIDONE	PD-Rx Pharmaceuticals, Inc.	bb7112ae-3a37-4525-8c7f-c0f4100ffc0a	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086831 application number: ANDA086831 ndc (product): 55289-067
Chlorthalidone	CHLORTHALIDONE	Safecor Health, LLC	e0e316f6-96d1-4a89-a3b9-f4f0b4c9c833	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086831 application number: ANDA086831
Chlorthalidone	CHLORTHALIDONE	Mylan Pharmaceuticals Inc.	15dd224a-87ad-48dc-80b1-e8382a452c4c	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086831 application number: ANDA086831 ndc (product): 0378-0222 ndc (product): 0378-0213
Chlorthalidone	CHLORTHALIDONE	Mylan Institutional Inc.	193c85ba-43c2-4be2-82cf-7b394a83390e	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086831 application number: ANDA086831 ndc (product): 51079-058

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 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0213	Chlorthalidone	chlorthalidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0213	Chlorthalidone	chlorthalidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0213	Chlorthalidone	chlorthalidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0213	Chlorthalidone	chlorthalidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0222	Chlorthalidone	chlorthalidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0222	Chlorthalidone	chlorthalidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0222	Chlorthalidone	chlorthalidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0222	Chlorthalidone	chlorthalidone	Mylan Pharmaceuticals Inc.	ANDA	Current
21695-671	Chlorthalidone	chlorthalidone	Rebel Distributors Corp	ANDA	Current
43353-922	Chlorthalidone	chlorthalidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-0144	Chlorthalidone	chlorthalidone	A-S Medication Solutions	ANDA	Current
50090-0144	Chlorthalidone	chlorthalidone	A-S Medication Solutions	ANDA	Current
50090-0145	Chlorthalidone	chlorthalidone	A-S Medication Solutions	ANDA	Current
50090-0145	Chlorthalidone	chlorthalidone	A-S Medication Solutions	ANDA	Current
51079-058	Chlorthalidone	chlorthalidone	Mylan Institutional Inc.	ANDA	Current
51079-058	Chlorthalidone	chlorthalidone	Mylan Institutional Inc.	ANDA	Current
51079-058	Chlorthalidone	chlorthalidone	Mylan Institutional Inc.	ANDA	Current
55289-067	Chlorthalidone	chlorthalidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-067	Chlorthalidone	chlorthalidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-067	Chlorthalidone	chlorthalidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-067	Chlorthalidone	chlorthalidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-067	Chlorthalidone	chlorthalidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-067	Chlorthalidone	chlorthalidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55700-297	Chlorthalidone	chlorthalidone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
63629-5259	Chlorthalidone	chlorthalidone	Bryant Ranch Prepack	ANDA	Current
63629-5259	Chlorthalidone	chlorthalidone	Bryant Ranch Prepack	ANDA	Current
63629-6347	Chlorthalidone	chlorthalidone	Bryant Ranch Prepack	ANDA	Current
63629-6347	Chlorthalidone	chlorthalidone	Bryant Ranch Prepack	ANDA	Current
70518-1683	Chlorthalidone	chlorthalidone	REMEDYREPACK INC.	ANDA	Current
70518-1683	Chlorthalidone	chlorthalidone	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85382	SUPPL	2026-03-16