Application 213392

Type: ANDA
Sponsor: GRANULES PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	SOLUTION;ORAL	20MEQ/15ML	No	No
002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	SOLUTION;ORAL	40MEQ/15ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A213392-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA		2021-01-29
A213392-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA		2021-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213392-001	AA
A213392-002	AA

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 · 76 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
2026-10-15 13:18:30	2026-09	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213392-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213392-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-01-29	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A213392-001	AA	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213392-002	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A213392-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213392-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213392-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213392-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213392-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213392-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213392-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213392-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213392-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213392-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213392-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213392-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213392-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213392-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213392-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213392-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213392-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213392-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213392-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213392-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213392-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213392-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213392-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213392-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213392-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213392-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213392-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213392-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213392-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213392-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213392-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213392-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213392-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213392-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213392-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213392-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213392-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213392-002	AA	1	`4b0b4de00fa7…`

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 · 189 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	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	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
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	A-S Medication Solutions	d486f982-a7d3-463d-a68d-89365ddaf5bb	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	4a2173ba-556b-4ad7-be81-4da79b739490	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: Potassium chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	6fc9eef0-3dfc-4344-85c7-9f11d9b99b65	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	1b64b0c9-31a2-4ee7-8818-66de906ebeda	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	0ac9b8dc-0c8e-4cdc-ab9d-bd8cab4f4958	2025-11-05	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride 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
70010-072	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-072	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-073	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-073	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current