Application 203562

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	TABLET, EXTENDED RELEASE;ORAL	10MEQ	No	No
002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	20MEQ	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
A203562-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-07-26
A203562-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203562-001	AB1
A203562-002	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 3 · 82 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	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A203562-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203562-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203562-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203562-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203562-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203562-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203562-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203562-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203562-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203562-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203562-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203562-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203562-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203562-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203562-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203562-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203562-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203562-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203562-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203562-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203562-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203562-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203562-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203562-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203562-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203562-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203562-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203562-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203562-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203562-002	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203562-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203562-002	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203562-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203562-002	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203562-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203562-002	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203562-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203562-002	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203562-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203562-002	AB1	1	`782e0a99824c…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
potassium chloride	POTASSIUM CHLORIDE	Glenmark Pharmaceuticals Inc., USA	63bedd99-0596-49d2-ad04-d1d8ac15cc42	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203562 application number: ANDA203562 ndc (product): 68462-472 ndc (product): 68462-471
potassium chloride	POTASSIUM CHLORIDE	Redpharm Drug	3735d41a-7787-6b92-e063-6294a90add45	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203562 application number: ANDA203562
Potassium Chloride ER	POTASSIUM CHLORIDE ER	Direct_Rx	f988aa11-60ef-411e-e053-6294a90a522a	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203562 application number: ANDA203562
potassium chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	3a720078-f455-44ab-a883-e3c13d83a74c	2024-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203562 application number: ANDA203562
potassium chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	cf014023-5300-455f-9f7f-fefb2e363986	2024-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203562 application number: ANDA203562
potassium chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	f22606a5-ac9f-44fc-bb7b-08f3cf56c999	2024-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203562 application number: ANDA203562 ndc (product): 71335-1109
potassium chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	bc42a691-a486-4ece-b9f7-faf6cc5df6b5	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203562 application number: ANDA203562 ndc (product): 71335-1781

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55700-880	potassium chloride	potassium chloride	Quality Care Products, LLC	ANDA	Current
55700-880	potassium chloride	potassium chloride	Quality Care Products, LLC	ANDA	Current
60687-561	Potassium Chloride	Potassium Chloride	American Health Packaging	ANDA	Current
60760-068	potassium chloride	potassium chloride	St. Mary's Medical Park Pharmacy	ANDA	Current
68001-367	potassium chloride	potassium chloride	BluePoint Laboratories	ANDA	Current
68001-367	potassium chloride	potassium chloride	BluePoint Laboratories	ANDA	Current
68001-367	potassium chloride	potassium chloride	BluePoint Laboratories	ANDA	Current
68001-445	potassium chloride	potassium chloride	BluePoint Laboratories	ANDA	Current
68071-4716	potassium chloride	potassium chloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4716	potassium chloride	potassium chloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4716	potassium chloride	potassium chloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68462-471	potassium chloride	potassium chloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-471	potassium chloride	potassium chloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-471	potassium chloride	potassium chloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-471	potassium chloride	potassium chloride	Glenmark Pharmaceuticals	ANDA	Current
68462-472	potassium chloride	potassium chloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-472	potassium chloride	potassium chloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-472	potassium chloride	potassium chloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-472	potassium chloride	potassium chloride	Glenmark Pharmaceuticals	ANDA	Current
70518-2234	potassium chloride	potassium chloride	REMEDYREPACK INC.	ANDA	Current
70518-2234	potassium chloride	potassium chloride	REMEDYREPACK INC.	ANDA	Current
70518-2234	potassium chloride	potassium chloride	REMEDYREPACK INC.	ANDA	Current
71335-1109	potassium chloride	potassium chloride	Bryant Ranch Prepack	ANDA	Current
71335-1781	potassium chloride	potassium chloride	Bryant Ranch Prepack	ANDA	Current
71335-1781	potassium chloride	potassium chloride	Bryant Ranch Prepack	ANDA	Current