Application 075604

Type: ANDA
Sponsor: ACTAVIS LABS FL 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	20MEQ	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075604-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2002-04-10
A075604-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2002-04-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075604-001	AB1
A075604-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075604-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075604-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-04-10	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075604-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075604-002	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075604-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075604-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075604-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075604-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075604-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075604-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075604-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075604-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075604-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075604-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075604-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075604-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075604-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075604-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075604-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075604-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075604-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075604-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075604-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075604-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075604-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075604-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075604-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075604-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075604-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075604-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075604-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075604-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075604-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075604-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075604-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075604-002	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075604-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075604-002	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075604-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075604-002	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075604-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075604-002	AB1	1	`74a2ff9319b5…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	American Health Packaging	b165ad93-1dc1-4863-9f0b-d7b97c42c94c	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075604 application number: ANDA075604
Potassium Chloride	POTASSIUM CHLORIDE	Proficient Rx LP	61daa681-05a0-4b2f-a6d0-c6fc1044f521	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075604 application number: ANDA075604
Potassium Chloride	POTASSIUM CHLORIDE	Actavis Pharma, Inc.	db002ae3-f54c-40a4-9cb4-e5681bf426e3	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075604 application number: ANDA075604 ndc (product): 62037-710

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8013	Potassium Chloride	Potassium Chloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8013	Potassium Chloride	Potassium Chloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
21695-711	Potassium Chloride	Potassium Chloride	Rebel Distributors Corp	ANDA	Current
21695-712	Potassium Chloride	Potassium Chloride	Rebel Distributors Corp	ANDA	Current
33261-376	Potassium Chloride	Potassium Chloride	Aidarex Pharmaceuticals LLC	ANDA	Current
55289-359	Potassium Chloride	Potassium Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-359	Potassium Chloride	Potassium Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-359	Potassium Chloride	Potassium Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-359	Potassium Chloride	Potassium Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-359	Potassium Chloride	Potassium Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
62037-710	Potassium Chloride	Potassium Chloride	Actavis Pharma, Inc.	ANDA	Current
62037-710	Potassium Chloride	Potassium Chloride	Actavis Pharma, Inc.	ANDA	Current
62037-710	Potassium Chloride	Potassium Chloride	Actavis Pharma, Inc.	ANDA	Current
62037-710	Potassium Chloride	Potassium Chloride	Actavis Pharma, Inc.	ANDA	Current
63629-7796	Potassium Chloride	Potassium Chloride	Bryant Ranch Prepack	ANDA	Current
63629-7796	Potassium Chloride	Potassium Chloride	Bryant Ranch Prepack	ANDA	Current
67296-1006	Potassium Chloride	Potassium Chloride	RedPharm Drug, Inc.	ANDA	Current
67296-1006	Potassium Chloride	Potassium Chloride	RedPharm Drug, Inc.	ANDA	Current
67296-1006	Potassium Chloride	Potassium Chloride	RedPharm Drug, Inc.	ANDA	Current
68001-303	Potassium Chloride	Potassium Chloride	BluePoint Laboratories	ANDA	Current
68084-632	Potassium Chloride	Potassium Chloride	American Health Packaging	ANDA	Current
68084-632	Potassium Chloride	Potassium Chloride	American Health Packaging	ANDA	Current
68084-632	Potassium Chloride	Potassium Chloride	American Health Packaging	ANDA	Current
68084-632	Potassium Chloride	Potassium Chloride	American Health Packaging	ANDA	Current
68084-632	Potassium Chloride	Potassium Chloride	American Health Packaging	ANDA	Current
70518-1068	Potassium Chloride	Potassium Chloride	REMEDYREPACK INC.	ANDA	Current
70518-1068	Potassium Chloride	Potassium Chloride	REMEDYREPACK INC.	ANDA	Current
71335-0289	Potassium Chloride	Potassium Chloride	Bryant Ranch Prepack	ANDA	Current
71335-0289	Potassium Chloride	Potassium Chloride	Bryant Ranch Prepack	ANDA	Current
71335-0289	Potassium Chloride	Potassium Chloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30954	ORIG	2003-04-10