Application 211648

Type: ANDA
Sponsor: SAPTALIS 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 1.

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
A211648-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA		2021-05-21
A211648-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA		2021-05-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211648-001	AA
A211648-002	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 · 66 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
2026-02-19 14:30 UTC	2026-02	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211648-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211648-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211648-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211648-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211648-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211648-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211648-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211648-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211648-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211648-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211648-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211648-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211648-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211648-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211648-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211648-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211648-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211648-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211648-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211648-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211648-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211648-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211648-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211648-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211648-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211648-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211648-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211648-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211648-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211648-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211648-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211648-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211648-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211648-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211648-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211648-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211648-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211648-002	AA	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211648-001	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211648-002	AA	1	`6a51e52b5d6a…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE ORAL	Saptalis Pharmaceuticals, LLC	483f338e-a164-4c1f-a34e-fef3312cb7ec	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211648 application number: ANDA211648
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE ORAL	ATLANTIC BIOLOGICALS CORP.	dc55474c-cc51-4f17-8cb3-0f34b3e68a55	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211648 application number: ANDA211648
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	American Health Packaging	7956883f-0d31-4081-bbea-d9ea320a193b	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211648 application number: ANDA211648 ndc (product): 60687-628
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE ORAL	American Health Packaging	7c8dd5b0-db93-430f-8bf8-0318504f744c	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211648 application number: ANDA211648
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Kesin Pharma Corporation	25c2b417-eeea-4ba6-8eb9-a7d8a08c6093	2024-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211648 application number: ANDA211648 ndc (product): 81033-240 ndc (product): 81033-220

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42571-357	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	MICRO LABS LIMITED	ANDA	Current
42571-358	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	MICRO LABS LIMITED	ANDA	Current
60687-628	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	American Health Packaging	ANDA	Current
81033-220	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Kesin Pharma Corporation	ANDA	Current
81033-240	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Kesin Pharma Corporation	ANDA	Current