Application 077419

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	CAPSULE, EXTENDED RELEASE;ORAL	8MEQ	No	No
002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MEQ	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077419-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02
A077419-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077419-001	AB
A077419-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077419-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-06-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077419-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2008-06-02	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077419-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077419-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077419-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077419-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077419-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077419-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077419-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077419-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077419-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077419-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077419-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077419-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077419-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077419-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077419-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077419-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077419-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077419-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077419-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077419-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077419-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077419-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077419-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077419-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077419-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077419-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077419-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077419-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077419-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077419-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077419-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077419-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077419-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077419-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077419-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077419-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077419-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077419-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077419-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077419-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	AvKARE	755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077419 application number: ANDA077419 ndc (product): 42291-678 ndc (product): 42291-679
Potassium Chloride	POTASSIUM CHLORIDE	Actavis Pharma, Inc.	ed5baaf6-270b-4dd3-b100-36030c0098fc	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077419 application number: ANDA077419 ndc (product): 62037-560 ndc (product): 62037-559

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-1318	Potassium Chloride	Potassium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6068	Potassium Chloride	potassium chloride	Major Pharmaceuticals	ANDA	Current
0904-6068	Potassium Chloride	potassium chloride	Major Pharmaceuticals	ANDA	Current
42291-678	Potassium Chloride	Potassium Chloride	AvKARE, Inc.	ANDA	Current
42291-678	Potassium Chloride	Potassium Chloride	AvKARE, Inc.	ANDA	Current
42291-678	Potassium Chloride	Potassium Chloride	AvKARE, Inc.	ANDA	Current
42291-679	Potassium Chloride	Potassium Chloride	AvKARE, Inc.	ANDA	Current
42291-679	Potassium Chloride	Potassium Chloride	AvKARE, Inc.	ANDA	Current
42291-679	Potassium Chloride	Potassium Chloride	AvKARE, Inc.	ANDA	Current
42291-679	Potassium Chloride	Potassium Chloride	AvKARE	ANDA	Current
55154-3328	Potassium Chloride	potassium chloride	Cardinal Health	ANDA	Current
55154-3328	Potassium Chloride	potassium chloride	Cardinal Health	ANDA	Current
55154-3328	Potassium Chloride	potassium chloride	Cardinal Health	ANDA	Current
55289-218	Potassium Chloride	Potassium Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-218	Potassium Chloride	Potassium Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-218	Potassium Chloride	Potassium Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-218	Potassium Chloride	Potassium Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
62037-559	Potassium Chloride	Potassium Chloride	Actavis Pharma, Inc.	ANDA	Current
62037-559	Potassium Chloride	Potassium Chloride	Actavis Pharma, Inc.	ANDA	Current
62037-559	Potassium Chloride	Potassium Chloride	Actavis Pharma, Inc.	ANDA	Current
62037-560	Potassium Chloride	Potassium Chloride	Actavis Pharma, Inc.	ANDA	Current
62037-560	Potassium Chloride	Potassium Chloride	Actavis Pharma, Inc.	ANDA	Current
62037-560	Potassium Chloride	Potassium Chloride	Actavis Pharma, Inc.	ANDA	Current
68071-3274	Potassium Chloride	Potassium Chloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68151-0609	Potassium Chloride	Potassium Chloride	Carilion Materials Management	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18461	ORIG	2012-11-27
22604	ORIG	2012-03-28