Application 214728

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	10MEQ	No	No
002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	15MEQ	No	No
003	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	20MEQ	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A214728-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31
A214728-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31
A214728-003	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31

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 2 of 3 · 108 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
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-03-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-03-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-03-31	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		2021-03-31	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214728-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214728-002	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214728-003	AB1	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	Aurobindo Pharma Limited	deb6b462-397f-4527-ae26-40dc5d5857bc	2021-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214728 application number: ANDA214728 ndc (product): 59651-431 ndc (product): 59651-430 ndc (product): 59651-429

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59651-429	Potassium Chloride	Potassium Chloride	Aurobindo Pharma Limited	ANDA	Current
59651-429	Potassium Chloride	Potassium Chloride	Aurobindo Pharma Limited	ANDA	Current
59651-430	Potassium Chloride	Potassium Chloride	Aurobindo Pharma Limited	ANDA	Current
59651-430	Potassium Chloride	Potassium Chloride	Aurobindo Pharma Limited	ANDA	Current
59651-431	Potassium Chloride	Potassium Chloride	Aurobindo Pharma Limited	ANDA	Current
59651-431	Potassium Chloride	Potassium Chloride	Aurobindo Pharma Limited	ANDA	Current