Application 210921

Type: ANDA
Sponsor: AUROBINDO PHARMA 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	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
A210921-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2		2018-12-19
A210921-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2		2018-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210921-001	AB2
A210921-002	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 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	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`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	A210921-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210921-002	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210921-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210921-002	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210921-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210921-002	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210921-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210921-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210921-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210921-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210921-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210921-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210921-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210921-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210921-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210921-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210921-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210921-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210921-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210921-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210921-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210921-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210921-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210921-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210921-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210921-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210921-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210921-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210921-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210921-002	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210921-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210921-002	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210921-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210921-002	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210921-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210921-002	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210921-001	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210921-002	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210921-001	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210921-002	AB2	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	REMEDYREPACK INC.	16c775e4-0dd8-4e9f-b2bf-dd2b639374cf	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921 ndc (product): 70518-2964
Potassium Chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	9088ca44-5585-4551-8e2c-168f306520d4	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921
Potassium Chloride	POTASSIUM CHLORIDE	Northwind Health Company, LLC	f3081031-8234-5732-e053-2995a90aebeb	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921
Potassium Chloride	POTASSIUM CHLORIDE	Major Pharmaceuticals	a9d68a40-75e3-4c5c-b5d7-1d6160527fa7	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921 ndc (product): 0904-7216
Potassium Chloride	POTASSIUM CHLORIDE	Preferred Pharmaceuticals Inc.	3f19ed0e-6c73-482c-94d6-d3205318fd6f	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921 ndc (product): 68788-8262
Potassium Chloride	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3dfa63fc-f8de-f1e0-e063-6294a90a8d47	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921
Potassium Chloride	POTASSIUM CHLORIDE	American Health Packaging	a67f5ba7-ac23-4bdc-9563-cb7fd049a951	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	e1670127-c551-441b-bac4-39f10a6d156f	2023-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921 ndc (product): 50090-5335
Potassium Chloride	POTASSIUM CHLORIDE	BluePoint Laboratories	73c911bb-4d39-4793-acba-90ed4b0eff46	2022-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921 ndc (product): 68001-518
Potassium Chloride	POTASSIUM CHLORIDE	Aurobindo Pharma Limited	d43beabe-b801-4319-ad36-9a80856b94bd	2021-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921 ndc (product): 65862-986 ndc (product): 65862-987

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7216	Potassium Chloride	Potassium Chloride	Major Pharmaceuticals	ANDA	Current
50090-5335	Potassium Chloride	Potassium Chloride	A-S Medication Solutions	ANDA	Current
50090-5335	Potassium Chloride	Potassium Chloride	A-S Medication Solutions	ANDA	Current
50090-5335	Potassium Chloride	Potassium Chloride	A-S Medication Solutions	ANDA	Current
65862-986	Potassium Chloride	Potassium Chloride	Aurobindo Pharma Limited	ANDA	Current
65862-986	Potassium Chloride	Potassium Chloride	Aurobindo Pharma Limited	ANDA	Current
65862-986	Potassium Chloride	Potassium Chloride	Aurobindo Pharma Limited	ANDA	Current
65862-986	Potassium Chloride	Potassium Chloride	Aurobindo Pharma Limited	ANDA	Current
65862-987	Potassium Chloride	Potassium Chloride	Aurobindo Pharma Limited	ANDA	Current
65862-987	Potassium Chloride	Potassium Chloride	Aurobindo Pharma Limited	ANDA	Current
65862-987	Potassium Chloride	Potassium Chloride	Aurobindo Pharma Limited	ANDA	Current
65862-987	Potassium Chloride	Potassium Chloride	Aurobindo Pharma Limited	ANDA	Current
68001-518	Potassium Chloride	Potassium Chloride	BluePoint Laboratories	ANDA	Current
68001-518	Potassium Chloride	Potassium Chloride	BluePoint Laboratories	ANDA	Current
68788-8262	Potassium Chloride	Potassium Chloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2964	Potassium Chloride	Potassium Chloride	REMEDYREPACK INC.	ANDA	Current
70518-2964	Potassium Chloride	Potassium Chloride	REMEDYREPACK INC.	ANDA	Current
70518-2964	Potassium Chloride	Potassium Chloride	REMEDYREPACK INC.	ANDA	Current
70518-2964	Potassium Chloride	Potassium Chloride	REMEDYREPACK INC.	ANDA	Current
70934-536	Potassium Chloride	Potassium Chloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current