Application 206630

Type: ANDA
Sponsor: PII

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	15MEQ	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A206630-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29
A206630-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29
A206630-003	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29

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 4 · 129 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	A206630-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206630-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206630-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206630-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206630-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206630-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206630-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206630-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206630-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206630-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206630-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206630-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206630-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206630-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206630-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206630-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206630-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206630-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206630-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206630-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206630-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206630-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206630-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206630-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206630-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206630-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206630-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206630-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206630-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206630-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206630-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206630-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206630-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206630-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206630-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206630-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206630-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206630-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206630-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206630-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2019-03-29	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A206630-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206630-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206630-003	AB1	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A206630-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206630-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206630-003	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206630-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206630-002	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206630-003	AB1	1	`ea99ee380514…`

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 8 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	XLCare Pharmaceuticals, Inc.	7fd82f08-8ad0-4ee2-8eb6-5c973f98baee	2024-05-21	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	7a220e87-ff72-417b-bc45-90a37b7f2aa6	2024-05-21	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Camber Pharmaceuticals, Inc.	b1e827aa-b2fb-4fa5-984d-ddd94338ff53	2024-05-14	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE	Fresenius Kabi USA, LLC	55d9ae37-4553-47e7-a2e3-86b48b5227cd	2024-05-08	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Bryant Ranch Prepack	65e30d1a-50e9-4b84-ad4d-daaea91eab4b	2024-04-09	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
POKONZA	POTASSIUM CHLORIDE	Carwin Pharmaceutical Associates, LLC	7c5cc705-e5da-4487-86c9-9d545a95afb4	2024-03-22	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Kesin Pharma Corporation	25c2b417-eeea-4ba6-8eb9-a7d8a08c6093	2024-03-12	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Proficient Rx LP	61daa681-05a0-4b2f-a6d0-c6fc1044f521	2024-02-01	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Lupin Pharmaceuticals,Inc.	fe08221d-74d5-490a-8db4-eaf3ed20b289	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	American Health Packaging	a67f5ba7-ac23-4bdc-9563-cb7fd049a951	2024-01-22	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Sun Pharmaceutical Industries, Inc.	4d90d03d-7f0e-4d49-9e80-628dbc7165c0	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Sun Pharmaceutical Industries, Inc.	8ed8ea55-8b15-f718-e053-2a95a90a587a	2024-01-10	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Proficient Rx LP	d0ce0bdf-5f24-4093-813f-881c61d7fcc7	2024-01-01	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Adare Pharmaceuticals Inc	22edb0e6-4e45-4e91-aead-3581cca293a0	2023-12-20	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	5aa0adf8-7b84-4cb0-be31-5c3333a6cc44	2023-12-11	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	5c4b0be5-625e-435f-9d2c-9d8fb407a8ea	2023-12-05	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	d033c3b3-3ed6-4f23-a555-bae40cf0c48f	2023-12-05	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Sun Pharmaceutical Industries, Inc.	0a1f2f64-3b0b-5e5c-e063-6294a90a7185	2023-11-14	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	86093c75-6de0-bb16-e053-2991aa0ab6ef	2023-11-13		Name fallback generic name: POTASSIUM CHLORIDE
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	86090ebb-0fb2-2c9c-e053-2a91aa0a0561	2023-11-13		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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42543-124	Potassium Chloride	Potassium Chloride	Vensun Pharmaceuticals, Inc.	ANDA	Current
42543-125	Potassium Chloride	Potassium Chloride	Vensun Pharmaceuticals, Inc.	ANDA	Current
42543-126	Potassium Chloride	Potassium Chloride	Vensun Pharmaceuticals, Inc.	ANDA	Current