Application 209922

Type: ANDA
Sponsor: PRINSTON INC

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 42.

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	TE codes	Approval date
A209922-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30
A209922-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30
A209922-003	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A209922-001	AB1
A209922-002	AB1
A209922-003	AB1

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 · 126 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
2026-08-18 06:07:40	2026-07	A209922-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209922-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209922-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209922-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209922-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209922-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209922-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209922-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209922-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209922-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209922-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209922-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209922-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209922-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209922-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209922-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209922-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209922-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209922-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209922-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209922-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209922-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209922-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209922-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209922-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209922-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209922-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209922-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209922-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209922-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209922-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209922-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209922-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209922-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209922-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209922-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209922-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209922-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209922-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209922-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-04-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209922-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209922-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209922-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209922-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209922-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209922-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209922-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209922-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209922-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209922-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209922-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209922-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209922-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209922-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209922-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209922-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209922-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209922-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209922-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209922-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209922-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209922-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209922-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209922-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209922-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209922-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209922-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209922-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209922-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209922-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209922-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209922-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209922-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209922-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209922-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209922-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209922-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209922-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209922-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209922-001	AB1	1	`1e350fbaab3a…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE EXTENDED-RELEASE	Solco Healthcare LLC	f704b746-ab75-4484-8704-5baa94a07750	2019-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209922 application number: ANDA209922 ndc (product): 43547-549 ndc (product): 43547-551 ndc (product): 43547-550

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
43547-549	POTASSIUM CHLORIDE	potassium chloride extended-release	Solco Healthcare LLC	ANDA	Current
43547-550	POTASSIUM CHLORIDE	potassium chloride extended-release	Solco Healthcare LLC	ANDA	Current
43547-551	POTASSIUM CHLORIDE	potassium chloride extended-release	Solco Healthcare LLC	ANDA	Current