Application 214422

Type: ANDA
Sponsor: ASCENT PHARMS INC

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	15MEQ	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214422-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29
A214422-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29
A214422-003	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A214422-001	AB1
A214422-002	AB1
A214422-003	AB1

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 · 108 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	A214422-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214422-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214422-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214422-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214422-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214422-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214422-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214422-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214422-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214422-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214422-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214422-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214422-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214422-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214422-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214422-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214422-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214422-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214422-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214422-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214422-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214422-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214422-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214422-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214422-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214422-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214422-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214422-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214422-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214422-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214422-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214422-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214422-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214422-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214422-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214422-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214422-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214422-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214422-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214422-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-12-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 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	A214422-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214422-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214422-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214422-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214422-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214422-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214422-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214422-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214422-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214422-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214422-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214422-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214422-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214422-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214422-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214422-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214422-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214422-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214422-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214422-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214422-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214422-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214422-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214422-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214422-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214422-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214422-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214422-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214422-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214422-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214422-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214422-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214422-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214422-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214422-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214422-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214422-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214422-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214422-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214422-001	AB1	1	`1e350fbaab3a…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
potassium chloride	POTASSIUM CHLORIDE	Northstar Rx LLC	b19a3fbf-cdbb-4f86-ac61-5dfb07e0a51a	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214422 application number: ANDA214422
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	61fe55c2-fc9a-4fae-899a-06601baa78e1	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214422 application number: ANDA214422 ndc (product): 71610-632
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	A-S Medication Solutions	162a8ab5-76cf-48fa-8487-7780ed65647e	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214422 application number: ANDA214422
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	A-S Medication Solutions	14db14ba-fd0d-4b2a-9f1c-a62b3b82306f	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214422 application number: ANDA214422 ndc (product): 50090-6253
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Bryant Ranch Prepack	d396477a-6b15-4782-9c85-b9663b83c484	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214422 application number: ANDA214422 ndc (product): 71335-2045
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	XLCare Pharmaceuticals, Inc.	7fd82f08-8ad0-4ee2-8eb6-5c973f98baee	2024-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214422 application number: ANDA214422 ndc (product): 72865-195 ndc (product): 72865-194 ndc (product): 72865-196
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Camber Pharmaceuticals, Inc.	b1e827aa-b2fb-4fa5-984d-ddd94338ff53	2024-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214422 application number: ANDA214422 ndc (product): 31722-133 ndc (product): 31722-134 ndc (product): 31722-135

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-133	POTASSIUM CHLORIDE	Potassium CHLORIDE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-133	POTASSIUM CHLORIDE	Potassium CHLORIDE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-133	POTASSIUM CHLORIDE	Potassium CHLORIDE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-133	POTASSIUM CHLORIDE	Potassium CHLORIDE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-134	POTASSIUM CHLORIDE	Potassium Chloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-134	POTASSIUM CHLORIDE	Potassium Chloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-134	POTASSIUM CHLORIDE	Potassium Chloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-134	POTASSIUM CHLORIDE	Potassium Chloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-135	POTASSIUM CHLORIDE	Potassium Chloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-135	POTASSIUM CHLORIDE	Potassium Chloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-135	POTASSIUM CHLORIDE	Potassium Chloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-135	POTASSIUM CHLORIDE	Potassium Chloride	Camber Pharmaceuticals, Inc.	ANDA	Current
43602-283	POTASSIUM CHLORIDE	Potassium CHLORIDE	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-284	POTASSIUM CHLORIDE	Potassium Chloride	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-285	POTASSIUM CHLORIDE	Potassium Chloride	Ascent Pharmaceuticals, Inc.	ANDA	Current
50090-6253	POTASSIUM CHLORIDE	Potassium Chloride	A-S Medication Solutions	ANDA	Current
70518-3222	POTASSIUM CHLORIDE	Potassium CHLORIDE	REMEDYREPACK INC.	ANDA	Current
71335-2045	POTASSIUM CHLORIDE	Potassium Chloride	Bryant Ranch Prepack	ANDA	Current
71335-2045	POTASSIUM CHLORIDE	Potassium Chloride	Bryant Ranch Prepack	ANDA	Current
71610-632	POTASSIUM CHLORIDE	Potassium Chloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72865-194	POTASSIUM CHLORIDE	Potassium CHLORIDE	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-194	POTASSIUM CHLORIDE	Potassium CHLORIDE	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-194	POTASSIUM CHLORIDE	Potassium CHLORIDE	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-195	POTASSIUM CHLORIDE	Potassium Chloride	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-195	POTASSIUM CHLORIDE	Potassium Chloride	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-195	POTASSIUM CHLORIDE	Potassium Chloride	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-196	POTASSIUM CHLORIDE	Potassium Chloride	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-196	POTASSIUM CHLORIDE	Potassium Chloride	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-196	POTASSIUM CHLORIDE	Potassium Chloride	XLCare Pharmaceuticals, Inc.	ANDA	Current