Application 211797

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	TABLET, EXTENDED RELEASE;ORAL	8MEQ	No	No
002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MEQ	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
A211797-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2		2020-03-04
A211797-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2		2020-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211797-001	AB2
A211797-002	AB2

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 · 74 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	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211797-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211797-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-03-04	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A211797-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211797-002	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211797-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211797-002	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211797-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211797-002	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211797-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211797-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211797-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211797-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211797-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211797-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211797-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211797-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211797-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211797-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211797-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211797-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211797-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211797-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211797-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211797-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211797-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211797-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211797-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211797-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211797-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211797-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211797-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211797-002	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211797-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211797-002	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211797-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211797-002	AB2	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211797-001	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211797-002	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211797-001	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211797-002	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211797-001	AB2	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211797-002	AB2	1	`87673890dc5c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	REMEDYREPACK INC.	d1e55181-6f85-42c9-922c-808494b6399a	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211797 application number: ANDA211797
POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3b403d60-4246-d765-e063-6394a90a12e8	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211797 application number: ANDA211797
POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	9f8d2886-9ecd-4cbf-a84a-2d221cb3497c	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211797 application number: ANDA211797 ndc (product): 70010-021 ndc (product): 70010-022

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70010-021	POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-021	POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-021	POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-021	POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-021	POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-021	POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-022	POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-022	POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-022	POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-022	POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-022	POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-022	POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current