Application 212799

Type: ANDA
Sponsor: BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CITRATE	POTASSIUM CITRATE	TABLET, EXTENDED RELEASE;ORAL	10MEQ	No	No
002	POTASSIUM CITRATE	POTASSIUM CITRATE	TABLET, EXTENDED RELEASE;ORAL	15MEQ	No	No

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

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
A212799-001	POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB		2020-06-29
A212799-002	POTASSIUM CITRATE	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB		2020-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212799-001	AB
A212799-002	AB

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 · 78 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
2026-09-14 22:38:34	2026-08	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212799-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212799-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212799-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212799-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212799-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212799-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212799-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212799-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212799-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212799-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212799-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212799-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212799-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212799-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212799-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212799-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212799-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212799-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212799-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212799-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212799-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212799-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212799-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212799-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212799-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212799-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212799-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212799-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212799-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212799-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212799-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212799-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212799-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212799-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212799-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212799-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212799-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212799-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212799-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212799-002	AB	1	`bb7c543d1eb4…`

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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Citrate	POTASSIUM CITRATE	Golden State Medical Supply, Inc.	cb09c63d-f3f0-5d6b-e053-2995a90acd44	2023-10-31	Warnings, Adverse reactions	Name fallback brand name: Potassium Citrate generic name: POTASSIUM CITRATE
Potassium Citrate	POTASSIUM CITRATE	Zydus Lifesciences Limited	39f46084-fc4b-4bfc-91cb-9be7e647655a	2023-10-03	Warnings, Adverse reactions	Name fallback brand name: Potassium Citrate generic name: POTASSIUM CITRATE
Potassium Citrate	POTASSIUM CITRATE	Zydus Pharmaceuticals (USA) Inc.	1a839f91-9bbd-4f46-b350-c5e8074b5db7	2023-10-03	Warnings, Adverse reactions	Name fallback brand name: Potassium Citrate generic name: POTASSIUM CITRATE
POTASSIUM CITRATE	POTASSIUM CITRATE	Bryant Ranch Prepack	b977c77b-c212-408e-adac-61736e5ed362	2023-09-18	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CITRATE generic name: POTASSIUM CITRATE
POTASSIUM CITRATE	POTASSIUM CITRATE	Bryant Ranch Prepack	d2e6ef87-f5d7-409a-91ed-ff0a4763c3bd	2023-09-15	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CITRATE generic name: POTASSIUM CITRATE
Potassium Citrate	POTASSIUM CITRATE	Actavis Pharma, Inc.	ac173781-486b-461c-97ae-8b5c69e20792	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Potassium Citrate generic name: POTASSIUM CITRATE
POTASSIUM CITRATE	POTASSIUM CITRATE	XLCare Pharmaceuticals, Inc.	360a1012-4bdb-473a-8f1f-4550d3b51343	2022-01-21	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CITRATE generic name: POTASSIUM CITRATE
POTASSIUM CITRATE	POTASSIUM CITRATE	Camber Pharmaceuticals, Inc	ea933654-e8d2-4662-9a9a-4a6d79a9fb20	2022-01-19	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CITRATE generic name: POTASSIUM CITRATE
UROCIT-K	POTASSIUM CITRATE	Mission Pharmacal Company	72cdea1b-2240-41db-987d-86d5c6aaa978	2021-12-02	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CITRATE

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69452-193	Potassium Citrate	Potassium Citrate	Bionpharma Inc.	ANDA	Current
69452-193	Potassium Citrate	Potassium Citrate	Bionpharma Inc.	ANDA	Current
69452-194	Potassium Citrate	Potassium Citrate	Bionpharma Inc.	ANDA	Current
69452-194	Potassium Citrate	Potassium Citrate	Bionpharma Inc.	ANDA	Current