Application 212561

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	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 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
A212561-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2019-09-30
A212561-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2019-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212561-001	AB3
A212561-002	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 2 · 80 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	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212561-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212561-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-09-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A212561-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212561-002	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212561-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212561-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212561-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212561-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212561-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212561-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212561-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212561-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212561-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212561-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212561-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212561-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212561-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212561-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212561-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212561-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212561-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212561-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212561-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212561-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212561-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212561-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212561-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212561-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212561-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212561-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212561-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212561-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212561-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212561-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212561-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212561-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212561-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212561-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212561-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212561-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212561-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212561-002	AB3	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	542e16b0-44db-490f-b44e-4c88a6e3d8b8	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212561 application number: ANDA212561
Potassium Chloride	POTASSIUM CHLORIDE	Slate Run Pharmaceuticals, LLC	94ae03cc-b620-0dbb-e053-2a95a90a922c	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212561 application number: ANDA212561 ndc (product): 70436-153 ndc (product): 70436-152

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70436-152	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-152	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-152	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-152	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-152	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-153	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-153	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-153	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-153	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-153	Potassium Chloride	Potassium Chloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70934-924	Potassium Chloride	Potassium Chloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current