Application 214686

Type: ANDA
Sponsor: GRANULES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	8MEQ	No	No
002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	CAPSULE, 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
A214686-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2021-02-16
A214686-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2021-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214686-001	AB
A214686-002	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 · 70 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	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214686-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214686-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 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	A214686-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214686-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214686-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214686-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214686-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214686-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214686-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214686-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214686-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214686-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214686-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214686-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214686-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214686-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214686-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214686-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214686-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214686-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214686-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214686-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214686-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214686-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214686-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214686-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214686-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214686-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214686-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214686-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214686-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214686-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214686-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214686-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214686-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214686-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214686-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214686-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214686-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214686-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214686-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214686-002	AB	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	POTASSIUM CHLORIDE	REMEDYREPACK INC.	f75713cf-6902-4160-94cb-335a1ecdbbbe	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214686 application number: ANDA214686
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	2d67fc67-c99f-4df2-a1e7-4d369cce12c2	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214686 application number: ANDA214686
Potassium Chloride	POTASSIUM CHLORIDE	Granules India Ltd	113c031c-6de3-4497-a57d-9740b1ce08ac	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214686 application number: ANDA214686 ndc (product): 62207-915 ndc (product): 62207-914
Potassium Chloride	POTASSIUM CHLORIDE	BluePoint Laboratories	3709ee9a-f885-4a75-ab51-36e9e1ef0427	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214686 application number: ANDA214686
Potassium Chloride	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc	c1f4832d-4d5c-8c49-e053-2a95a90ac9fe	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214686 application number: ANDA214686 ndc (product): 70010-147 ndc (product): 70010-148
Potassium Chloride	POTASSIUM CHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	f1791d4f-029a-487f-aee1-fc5be246d0bc	2024-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214686 application number: ANDA214686 ndc (product): 0615-8442

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8442	Potassium Chloride	Potassium Chloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
62207-914	Potassium Chloride	Potassium Chloride	Granules India Ltd	ANDA	Current
62207-915	Potassium Chloride	Potassium Chloride	Granules India Ltd	ANDA	Current
70010-147	Potassium Chloride	Potassium Chloride	Granules Pharmaceuticals Inc	ANDA	Current
70010-147	Potassium Chloride	Potassium Chloride	Granules Pharmaceuticals Inc	ANDA	Current
70010-148	Potassium Chloride	Potassium Chloride	Granules Pharmaceuticals Inc	ANDA	Current
70010-148	Potassium Chloride	Potassium Chloride	Granules Pharmaceuticals Inc	ANDA	Current