Application 203546

Type: ANDA
Sponsor: ZYDUS PHARMS

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
A203546-001	POTASSIUM CITRATE	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06
A203546-002	POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06
A203546-003	POTASSIUM CITRATE	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203546-001	AB
A203546-002	AB
A203546-003	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	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`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	A203546-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203546-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203546-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203546-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203546-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203546-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203546-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203546-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203546-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203546-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203546-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203546-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203546-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203546-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203546-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203546-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203546-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203546-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203546-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203546-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203546-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203546-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203546-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203546-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203546-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203546-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203546-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203546-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203546-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203546-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203546-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203546-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203546-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203546-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203546-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203546-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203546-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203546-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203546-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203546-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Citrate	POTASSIUM CITRATE	American Health Packaging	1201c777-2388-4235-bb8f-eb7dc1e867f8	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203546 application number: ANDA203546 ndc (product): 68084-850
Potassium Citrate	POTASSIUM CITRATE	Golden State Medical Supply, Inc.	cb09c63d-f3f0-5d6b-e053-2995a90acd44	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203546 application number: ANDA203546 ndc (product): 51407-451 ndc (product): 51407-450 ndc (product): 51407-449
Potassium Citrate	POTASSIUM CITRATE	Zydus Lifesciences Limited	39f46084-fc4b-4bfc-91cb-9be7e647655a	2023-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203546 application number: ANDA203546 ndc (product): 65841-538 ndc (product): 65841-536 ndc (product): 65841-537
Potassium Citrate	POTASSIUM CITRATE	Zydus Pharmaceuticals (USA) Inc.	1a839f91-9bbd-4f46-b350-c5e8074b5db7	2023-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203546 application number: ANDA203546 ndc (product): 68382-537 ndc (product): 68382-536 ndc (product): 68382-538

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-449	Potassium Citrate	Potassium Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-449	Potassium Citrate	Potassium Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-449	Potassium Citrate	Potassium Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-449	Potassium Citrate	Potassium Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-450	Potassium Citrate	Potassium Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-450	Potassium Citrate	Potassium Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-450	Potassium Citrate	Potassium Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-450	Potassium Citrate	Potassium Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-451	Potassium Citrate	Potassium Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-451	Potassium Citrate	Potassium Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-451	Potassium Citrate	Potassium Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-451	Potassium Citrate	Potassium Citrate	Golden State Medical Supply, Inc.	ANDA	Current
65841-536	Potassium Citrate	Potassium Citrate	Cadila Healthcare Limited	ANDA	Current
65841-536	Potassium Citrate	Potassium Citrate	Cadila Healthcare Limited	ANDA	Current
65841-536	Potassium Citrate	Potassium Citrate	Cadila Healthcare Limited	ANDA	Current
65841-537	Potassium Citrate	Potassium Citrate	Cadila Healthcare Limited	ANDA	Current
65841-537	Potassium Citrate	Potassium Citrate	Cadila Healthcare Limited	ANDA	Current
65841-537	Potassium Citrate	Potassium Citrate	Cadila Healthcare Limited	ANDA	Current
65841-538	Potassium Citrate	Potassium Citrate	Cadila Healthcare Limited	ANDA	Current
65841-538	Potassium Citrate	Potassium Citrate	Cadila Healthcare Limited	ANDA	Current
65841-538	Potassium Citrate	Potassium Citrate	Cadila Healthcare Limited	ANDA	Current
68084-850	Potassium Citrate	Potassium Citrate	American Health Packaging	ANDA	Current
68084-850	Potassium Citrate	Potassium Citrate	American Health Packaging	ANDA	Current
68084-850	Potassium Citrate	Potassium Citrate	American Health Packaging	ANDA	Current
68382-536	Potassium Citrate	Potassium Citrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-536	Potassium Citrate	Potassium Citrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-536	Potassium Citrate	Potassium Citrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-536	Potassium Citrate	Potassium Citrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-537	Potassium Citrate	Potassium Citrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-537	Potassium Citrate	Potassium Citrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-537	Potassium Citrate	Potassium Citrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-537	Potassium Citrate	Potassium Citrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-538	Potassium Citrate	Potassium Citrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-538	Potassium Citrate	Potassium Citrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-538	Potassium Citrate	Potassium Citrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-538	Potassium Citrate	Potassium Citrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current