Application 213588

Type: ANDA
Sponsor: CENTAUR PHARMS PVT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MEQ	No	No
002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	20MEQ	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
A213588-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL			2020-08-21
A213588-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL			2020-08-21

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 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213588-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213588-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2020-08-21	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	A213588-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213588-002	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213588-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A213588-002	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213588-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A213588-002	AB1	1	`c0c555d07b60…`

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 · 200 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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
Potassium Chloride	POTASSIUM CHLORIDE	Endo USA, Inc.	e5214432-3517-4a90-9412-036752bd1139	2025-02-10	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

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
64330-613	Potassium Chloride	Potassium Chloride	Centaur Pharmaceuticals Private Limited	ANDA	Current
64330-613	Potassium Chloride	Potassium Chloride	Centaur Pharmaceuticals Private Limited	ANDA	Current
64330-615	Potassium Chloride	Potassium Chloride	Centaur Pharmaceuticals Private Limited	ANDA	Current
64330-615	Potassium Chloride	Potassium Chloride	Centaur Pharmaceuticals Private Limited	ANDA	Current