Application 206759

Type: ANDA
Sponsor: NOVEL LABS 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	8MEQ	No	No
002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MEQ	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
A206759-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2		2016-08-09
A206759-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2		2016-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206759-001	AB2
A206759-002	AB2

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	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206759-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206759-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-09	`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	A206759-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206759-002	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206759-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206759-002	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206759-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206759-002	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206759-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206759-002	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206759-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206759-002	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206759-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206759-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206759-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206759-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206759-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206759-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206759-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206759-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206759-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206759-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206759-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206759-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206759-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206759-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206759-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206759-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206759-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206759-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206759-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206759-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206759-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206759-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206759-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206759-002	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206759-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206759-002	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206759-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206759-002	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206759-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206759-002	AB2	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 3 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	Northwind Health Company, LLC	db4dc4ab-e0d4-7dc7-e053-2995a90ac46e	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	471f3a39-5fea-cd7a-e063-6294a90a0d93	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Northwind Health Company, LLC	0a72cc27-e092-d85a-e063-6294a90a503c	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	BPI Labs LLC	aeb2e14e-cd7c-49d0-a15f-fbbe89a03c6b	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
potassium chloride	POTASSIUM CHLORIDE	Redpharm Drug	3735d41a-7787-6b92-e063-6294a90add45	2025-12-24	Warnings, Adverse reactions	Name fallback brand name: potassium chloride generic name: POTASSIUM CHLORIDE
POKONZA	POTASSIUM CHLORIDE	Carwin Pharmaceutical Associates, LLC	0700c19e-abca-4527-8944-e4440a32e3af	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE ORAL	ATLANTIC BIOLOGICALS CORP.	dc55474c-cc51-4f17-8cb3-0f34b3e68a55	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	IPG Pharmaceuticals, Inc.	5dad0879-0f97-4c7d-98fa-baaed51cd2d8	2025-12-09	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Granules India Ltd	113c031c-6de3-4497-a57d-9740b1ce08ac	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride for Oral Solution	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	727be945-df2a-4fbf-ade4-f242e2647976	2025-12-02	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	302b3fa7-ea87-4bf1-aae0-6a2d7459de86	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium chloride	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	42773f05-7c2c-1790-e063-6294a90a78b3	2025-11-24	Warnings, Adverse reactions	Name fallback brand name: Potassium chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Aurobindo Pharma Limited	b17d54ca-5885-48d3-96e9-b29ad14f8d76	2025-11-24	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium chloride	POTASSIUM CHLORIDE	Advagen Pharma Ltd	8000e242-fe20-4d02-8f7d-97298857cf4c	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Potassium chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	AvPAK	6bb3f62d-79ce-cee6-8c6c-ee1eb6121f01	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	61fe55c2-fc9a-4fae-899a-06601baa78e1	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	PD-Rx Pharmaceuticals, Inc.	018fc687-1fba-202e-e063-6294a90a5c9a	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	BluePoint Laboratories	3709ee9a-f885-4a75-ab51-36e9e1ef0427	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Henry Schein, Inc.	8367a2ae-dfd9-4515-838c-529920291ca0	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	2feda15e-f325-41fe-a442-41a8cc62b855	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
40032-912	potassium chloride	potassium chloride	Novel Laboratories, Inc.	ANDA	Current
40032-912	potassium chloride	potassium chloride	Novel Laboratories, Inc.	ANDA	Current
40032-913	potassium chloride	potassium chloride	Novel Laboratories, Inc.	ANDA	Current
40032-913	potassium chloride	potassium chloride	Novel Laboratories, Inc.	ANDA	Current