Application 202868

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MEQ	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202868-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL			2016-01-19

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 · 42 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	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-01-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-01-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202868-001	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-01-19	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202868-001	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202868-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202868-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202868-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202868-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202868-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202868-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202868-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202868-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202868-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202868-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202868-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202868-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202868-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202868-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202868-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202868-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202868-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202868-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202868-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202868-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202868-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202868-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202868-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202868-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202868-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202868-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202868-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202868-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202868-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202868-001	AB	1	`cb3db0bc1861…`

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	POTASSIUM CHLORIDE	BluePoint Laboratories	431ff2ef-567c-4b60-af43-f4da61febaad	2019-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202868 application number: ANDA202868 ndc (product): 68001-396
Potassium Chloride	POTASSIUM CHLORIDE	Northstar Rx LLC	dded25a9-3df4-463a-8685-d2bc03ea4edb	2018-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202868 application number: ANDA202868 ndc (product): 16714-824
Potassium Chloride	POTASSIUM CHLORIDE	Glenmark Pharmaceuticals Inc., USA	5b054142-7372-4641-be27-dca630a97ad9	2016-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202868 application number: ANDA202868 ndc (product): 68462-357

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-824	Potassium Chloride	Potassium Chloride	Northstar Rx LLC	ANDA	Current
60687-533	Potassium Chloride	Potassium Chloride	American Health Packaging	ANDA	Current
68001-396	Potassium Chloride	Potassium Chloride	BluePoint Laboratories	ANDA	Current
68071-3153	Potassium Chloride	Potassium Chloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3153	Potassium Chloride	Potassium Chloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3153	Potassium Chloride	Potassium Chloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68462-357	Potassium Chloride	Potassium Chloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
70518-1203	Potassium Chloride	Potassium Chloride	REMEDYREPACK INC.	ANDA	Current
70518-1203	Potassium Chloride	Potassium Chloride	REMEDYREPACK INC.	ANDA	Current
70518-1203	Potassium Chloride	Potassium Chloride	REMEDYREPACK INC.	ANDA	Current
70518-1203	Potassium Chloride	Potassium Chloride	REMEDYREPACK INC.	ANDA	Current
70518-1203	Potassium Chloride	Potassium Chloride	REMEDYREPACK INC.	ANDA	Current
70934-765	Potassium Chloride	Potassium Chloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current