Application 209688

Type: ANDA
Sponsor: VITRUVIAS THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MEQ	No	No
002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	20MEQ	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
A209688-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12
A209688-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	RS	2018-01-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209688-001	AB3
A209688-002	AB3

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	RS	2018-01-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	RS	2018-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	RS	2018-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	RS	2018-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	RS	2018-01-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	RS	2018-01-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	RS	2018-01-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	RS	2018-01-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	RS	2018-01-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	RS	2018-01-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	RS	2018-01-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	RS	2018-01-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	RS	2018-01-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	RS	2018-01-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209688-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209688-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-01-12	`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	A209688-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209688-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209688-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209688-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209688-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209688-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209688-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209688-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209688-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209688-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209688-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209688-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209688-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209688-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209688-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209688-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209688-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209688-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209688-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209688-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209688-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209688-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209688-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209688-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209688-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209688-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209688-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209688-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209688-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209688-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209688-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209688-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209688-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209688-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209688-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209688-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209688-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209688-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209688-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209688-002	AB3	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	02707146-331f-4511-a187-0152fc8bca85	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209688 application number: ANDA209688
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	A-S Medication Solutions	d486f982-a7d3-463d-a68d-89365ddaf5bb	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209688 application number: ANDA209688
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3be29fcc-765e-8653-e063-6394a90a59d5	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209688 application number: ANDA209688
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	8bae6f0f-58ca-490f-a725-8ec4bc6ba514	2024-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209688 application number: ANDA209688
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Proficient Rx LP	d0ce0bdf-5f24-4093-813f-881c61d7fcc7	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209688 application number: ANDA209688
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	A-S Medication Solutions	0dc6c066-1a59-4798-b9e6-d66872245389	2023-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209688 application number: ANDA209688

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43826-025	Potassium Chloride	Potassium Chloride	Bora Pharmaceutical Laboratories Inc.	ANDA	Current
43826-025	Potassium Chloride	Potassium Chloride	Bora Pharmaceutical Laboratories Inc.	ANDA	Current
43826-025	Potassium Chloride	Potassium Chloride	Bora Pharmaceutical Laboratories Inc.	ANDA	Current
43826-026	Potassium Chloride	Potassium Chloride	Bora Pharmaceutical Laboratories Inc.	ANDA	Current
43826-026	Potassium Chloride	Potassium Chloride	Bora Pharmaceutical Laboratories Inc.	ANDA	Current
43826-026	Potassium Chloride	Potassium Chloride	Bora Pharmaceutical Laboratories Inc.	ANDA	Current
69680-133	Potassium Chloride	Potassium Chloride	Vitruvias Therapeutics	ANDA	Current
69680-133	Potassium Chloride	Potassium Chloride	Vitruvias Therapeutics	ANDA	Current
69680-133	Potassium Chloride	Potassium Chloride	Vitruvias Therapeutics	ANDA	Current
69680-134	Potassium Chloride	Potassium Chloride	Vitruvias Therapeutics	ANDA	Current
69680-134	Potassium Chloride	Potassium Chloride	Vitruvias Therapeutics	ANDA	Current
69680-134	Potassium Chloride	Potassium Chloride	Vitruvias Therapeutics	ANDA	Current
70934-974	Potassium Chloride	Potassium Chloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current