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 6 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	American Health Packaging	b165ad93-1dc1-4863-9f0b-d7b97c42c94c	2025-06-23	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	a230185f-5493-487d-892a-5219869b4e47	2025-05-05	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	ab147ac2-d7d5-46d1-a2de-d866219197c1	2025-04-28	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Endo USA, Inc.	a64d7151-09a6-474c-83fc-36c7cf582d32	2025-03-26	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	bf632e1d-73f3-4df1-ad12-e555fa6a56e9	2025-02-27	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Kali Muriaticum Kit Refill	POTASSIUM CHLORIDE	Washington Homeopathic Products	099223af-a3f6-c370-e063-6394a90aa17f	2025-01-28	Warnings	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Direct_Rx	946b9568-671d-172a-e053-2a95a90ac827	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
D-125	POTASSIUM CHLORIDE	DNA Labs, Inc.	71b92f48-edee-49a4-a87f-7b284e1b45a0	2025-01-13	Warnings	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	81a53ecd-2612-4efe-9491-415fff3f86e5	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9508355e-e1ed-412b-e053-2a95a90aac8e	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	951ffdc3-d54f-d5e1-e053-2a95a90a79e6	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Proficient Rx LP	7238d1d5-23c1-44d5-98fc-20d1d4e5a8ce	2025-01-01	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	PAI Holdings, LLC dba PAI Pharma	e848477f-b10d-4249-b322-b70cd6a062de	2024-11-19	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
potassium chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	3a720078-f455-44ab-a883-e3c13d83a74c	2024-11-18	Warnings, Adverse reactions	Name fallback brand name: potassium chloride generic name: POTASSIUM CHLORIDE
potassium chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	cf014023-5300-455f-9f7f-fefb2e363986	2024-11-18	Warnings, Adverse reactions	Name fallback brand name: potassium chloride generic name: POTASSIUM CHLORIDE
potassium chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	f22606a5-ac9f-44fc-bb7b-08f3cf56c999	2024-11-12	Warnings, Adverse reactions	Name fallback brand name: potassium chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	American Health Packaging	96ea00f5-b922-4d57-b2ac-34523ea56d5f	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	55747ef3-9437-4bdc-9ebd-a74d8e2de1cf	2024-10-29	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	473369cb-3a9b-437c-b08e-8fb38034c507	2024-10-03	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride for Oral Solution	POTASSIUM CHLORIDE	Somerset Therapeutics, LLC	32809eae-1c3f-96fc-e063-6394a90aeaad	2024-09-30	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
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