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 5 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	AvKARE	3bdfced1-6e62-9e92-e063-6294a90a28aa	2025-08-08	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3be29fcc-765e-8653-e063-6394a90a59d5	2025-08-08	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Slate Run Pharmaceuticals, LLC	94ae03cc-b620-0dbb-e053-2a95a90a922c	2025-08-07	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Slate Run Pharmaceuticals, LLC	0cc57ece-f15a-4160-a5ea-8d6fa9f9e754	2025-08-07	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	PD-Rx Pharmaceuticals, Inc.	47a87fb6-5e61-41c9-b759-10f7c74a67ce	2025-08-05	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	American Health Packaging	7956883f-0d31-4081-bbea-d9ea320a193b	2025-08-04	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3b403d60-4246-d765-e063-6394a90a12e8	2025-07-31	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	A-S Medication Solutions	162a8ab5-76cf-48fa-8487-7780ed65647e	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	A-S Medication Solutions	14db14ba-fd0d-4b2a-9f1c-a62b3b82306f	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	AvKARE	8baf3f25-c78b-6c08-e053-2995a90a667e	2025-07-23	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	AvKARE	8bb030b7-104a-373b-e053-2995a90ab580	2025-07-23	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Guardian Drug Company	296eda62-ea8e-7a0c-e063-6294a90a9274	2025-07-22	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Genus Lifesciences	14cd12ee-a4a3-465a-9550-58c9ef0e4f21	2025-07-21	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium chloride	POTASSIUM CHLORIDE	Camber Pharmaceuticals, Inc.	fb2f6e74-4c1f-40c5-88a1-b88c069d4c75	2025-07-17	Warnings, Adverse reactions	Name fallback brand name: Potassium chloride generic name: POTASSIUM CHLORIDE
potassium chloride	POTASSIUM CHLORIDE	Solco Healthcare LLC	52d91d76-8c7f-40f1-9f5c-e05962cabedd	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: potassium chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	616f0de7-8843-44a1-8fa6-274d889286aa	2025-07-14	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
KLOR-CON	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	1ff53330-065c-4213-9c0c-ac498621d09d	2025-07-14	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
KLOR-CON	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	e61a4522-b91d-400a-952c-6f035e4610dd	2025-07-14	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
KLOR-CON M	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	b89910f6-4ff5-4a62-8269-696f7c10e4f6	2025-07-14	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Upsher-SmithLaboratories, LLC	ad584ce4-a64d-4851-80e9-0eeedc0b9d06	2025-07-10	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