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 10 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	Zydus Pharmaceuticals (USA) Inc.	51586c47-1aff-4ce6-8030-89f9eb1bc9ac	2021-02-08	Warnings, Adverse reactions	Name fallback brand name: potassium chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Lupin Pharmaceuticals,Inc.	28c49165-d8c9-443a-b000-953b8e1ec55c	2020-11-20	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Genus Lifesciences Inc.	23d818e7-c076-40de-8dc1-0b51ba4be96a	2020-04-28	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Lupin Pharmaceuticals,Inc.	1bbacdbb-91fa-4897-a00c-1b293de27b83	2020-04-27	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Mylan Pharmaceuticals Inc.	c64ed4c0-1e27-42b3-9625-fb4e0d31e271	2020-04-15	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	BluePoint Laboratories	431ff2ef-567c-4b60-af43-f4da61febaad	2019-07-03	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE EXTENDED-RELEASE	Solco Healthcare LLC	f704b746-ab75-4484-8704-5baa94a07750	2019-04-30	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Novel Laboratories, Inc.	ce4d4d39-8551-4789-8347-af763635922c	2018-11-28	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Northstar Rx LLC	dded25a9-3df4-463a-8685-d2bc03ea4edb	2018-07-16	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