Application 206813

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CITRATE	POTASSIUM CITRATE	TABLET, EXTENDED RELEASE;ORAL	5MEQ	No	No
002	POTASSIUM CITRATE	POTASSIUM CITRATE	TABLET, EXTENDED RELEASE;ORAL	10MEQ	No	No
003	POTASSIUM CITRATE	POTASSIUM CITRATE	TABLET, EXTENDED RELEASE;ORAL	15MEQ	No	No

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

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	TE codes	Approval date
A206813-001	POTASSIUM CITRATE	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11
A206813-002	POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11
A206813-003	POTASSIUM CITRATE	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A206813-001	AB
A206813-002	AB
A206813-003	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 4 · 126 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	A206813-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206813-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206813-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206813-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206813-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206813-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206813-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206813-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206813-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206813-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206813-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206813-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206813-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206813-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206813-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206813-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206813-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206813-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206813-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206813-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206813-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206813-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206813-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206813-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206813-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206813-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206813-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206813-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206813-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206813-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206813-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206813-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206813-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206813-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206813-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206813-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206813-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206813-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206813-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206813-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-11	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206813-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206813-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206813-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206813-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206813-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206813-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206813-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206813-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206813-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206813-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206813-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206813-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206813-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206813-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206813-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206813-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206813-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206813-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206813-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206813-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206813-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206813-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206813-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206813-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206813-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206813-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206813-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206813-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206813-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206813-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206813-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206813-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206813-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206813-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206813-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206813-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206813-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206813-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206813-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206813-001	AB	1	`1e350fbaab3a…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POTASSIUM CITRATE EXTENDED RELEASE	POTASSIUM CITRATE	Bryant Ranch Prepack	3dd9c9eb-df19-4ec9-bc77-f3a159b33d94	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206813 application number: ANDA206813
POTASSIUM CITRATE EXTENDED RELEASE	POTASSIUM CITRATE	Bryant Ranch Prepack	44ab2c4f-4a76-470d-98fb-8874c692a967	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206813 application number: ANDA206813
POTASSIUM CITRATE EXTENDED RELEASE	POTASSIUM CITRATE	Strides Pharma Inc.	5f38b02c-703c-4fc2-b833-654e41bd617f	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206813 application number: ANDA206813 ndc (product): 42543-407 ndc (product): 42543-406 ndc (product): 42543-408
POTASSIUM CITRATE EXTENDED RELEASE	POTASSIUM CITRATE	Bryant Ranch Prepack	8f5f7078-3c2d-406f-9222-b82a0f79d168	2025-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206813 application number: ANDA206813
POTASSIUM CITRATE EXTENDED RELEASE	POTASSIUM CITRATE	Bryant Ranch Prepack	b6ce81aa-ed9e-4eac-9f9c-26e2560f06db	2025-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206813 application number: ANDA206813
POTASSIUM CITRATE EXTENDED RELEASE	POTASSIUM CITRATE	Bryant Ranch Prepack	9774b7c5-4695-47c9-9eb8-e0af2e05f5c3	2024-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206813 application number: ANDA206813 ndc (product): 71335-1706

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42543-406	POTASSIUM CITRATE	POTASSIUM CITRATE	Strides Pharma Inc.	ANDA	Current
42543-406	POTASSIUM CITRATE	POTASSIUM CITRATE	Vensun Pharmaceuticals Inc	ANDA	Current
42543-406	POTASSIUM CITRATE	POTASSIUM CITRATE	Strides Pharma Inc.	ANDA	Current
42543-407	POTASSIUM CITRATE	POTASSIUM CITRATE	Strides Pharma Inc.	ANDA	Current
42543-407	POTASSIUM CITRATE	POTASSIUM CITRATE	Vensun Pharmaceuticals Inc	ANDA	Current
42543-407	POTASSIUM CITRATE	POTASSIUM CITRATE	Strides Pharma Inc.	ANDA	Current
42543-408	POTASSIUM CITRATE	POTASSIUM CITRATE	Strides Pharma Inc.	ANDA	Current
42543-408	POTASSIUM CITRATE	POTASSIUM CITRATE	Vensun Pharmaceuticals Inc	ANDA	Current
42543-408	POTASSIUM CITRATE	POTASSIUM CITRATE	Strides Pharma Inc.	ANDA	Current
70518-1221	POTASSIUM CITRATE	POTASSIUM CITRATE	REMEDYREPACK INC.	ANDA	Current
70518-1221	POTASSIUM CITRATE	POTASSIUM CITRATE	REMEDYREPACK INC.	ANDA	Current
70518-1221	POTASSIUM CITRATE	POTASSIUM CITRATE	REMEDYREPACK INC.	ANDA	Current
70518-1221	POTASSIUM CITRATE	POTASSIUM CITRATE	REMEDYREPACK INC.	ANDA	Current
70518-1221	POTASSIUM CITRATE	POTASSIUM CITRATE	REMEDYREPACK INC.	ANDA	Current
71335-1706	POTASSIUM CITRATE	POTASSIUM CITRATE	Bryant Ranch Prepack	ANDA	Current
71335-1706	POTASSIUM CITRATE	POTASSIUM CITRATE	Bryant Ranch Prepack	ANDA	Current
71335-1706	POTASSIUM CITRATE	POTASSIUM CITRATE	Bryant Ranch Prepack	ANDA	Current