Application 209314

Type: ANDA
Sponsor: YICHANG HUMANWELL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	8MEQ	No	No
002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MEQ	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209314-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2		2018-06-22
A209314-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2		2018-06-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209314-001	AB2
A209314-002	AB2

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 · 84 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
2026-08-18 06:07:40	2026-07	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209314-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209314-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-06-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209314-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209314-002	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209314-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209314-002	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209314-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209314-002	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209314-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209314-002	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209314-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209314-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209314-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209314-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209314-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209314-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209314-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209314-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209314-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209314-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209314-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209314-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209314-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209314-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209314-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209314-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209314-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209314-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209314-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209314-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209314-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209314-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209314-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209314-002	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209314-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209314-002	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209314-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209314-002	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209314-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209314-002	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209314-001	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209314-002	AB2	1	`bb7c543d1eb4…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	30527e49-6648-44f3-97b2-9c51783ac003	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209314 application number: ANDA209314
Potassium Chloride	POTASSIUM CHLORIDE	St. Mary's Medical Park Pharmacy	549c9d28-bf8b-2dc2-e063-6294a90abe7b	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209314 application number: ANDA209314
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	0ac9b8dc-0c8e-4cdc-ab9d-bd8cab4f4958	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209314 application number: ANDA209314
Potassium Chloride	POTASSIUM CHLORIDE	Epic Pharma, LLC	00615fad-ad3b-46e8-a89d-48290d937ae2	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209314 application number: ANDA209314
Potassium Chloride	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3dfac7ca-2c2e-e709-e063-6394a90adbb3	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209314 application number: ANDA209314
Potassium Chloride	POTASSIUM CHLORIDE	Slate Run Pharmaceuticals, LLC	0cc57ece-f15a-4160-a5ea-8d6fa9f9e754	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209314 application number: ANDA209314 ndc (product): 70436-002 ndc (product): 70436-001
Potassium Chloride	POTASSIUM CHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	bf632e1d-73f3-4df1-ad12-e555fa6a56e9	2025-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209314 application number: ANDA209314
Potassium Chloride	POTASSIUM CHLORIDE	Proficient Rx LP	7238d1d5-23c1-44d5-98fc-20d1d4e5a8ce	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209314 application number: ANDA209314

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70436-001	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-001	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-001	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-001	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-001	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-001	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-002	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-002	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-002	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-002	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-002	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-002	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current