Application 215750

Type: ANDA
Sponsor: UMEDICA LABS PVT LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	TABLET;ORAL	50MG	No	No
002	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	TABLET;ORAL	25MG	No	No

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

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
A215750-001	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		2022-05-11
A215750-002	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2025-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215750-001	AB
A215750-002	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.

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	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215750-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB	2025-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215750-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB	2025-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215750-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB	2025-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215750-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB	2025-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215750-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2022-05-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215750-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB	2025-06-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215750-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215750-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215750-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215750-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215750-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215750-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215750-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215750-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215750-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215750-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215750-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215750-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215750-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215750-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215750-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215750-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215750-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215750-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215750-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215750-001	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215750-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215750-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215750-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215750-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215750-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215750-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215750-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215750-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215750-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215750-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215750-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215750-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215750-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215750-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215750-002	AB	1	`a50c72e98297…`

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
Diclofenac Potassium	DICLOFENAC POTASSIUM TABLETS	Umedica Laboratories USA Inc.	1fa07fbe-3708-4200-b3ff-a920434896b6	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215750 application number: ANDA215750 ndc (product): 60290-057
Diclofenac Potassium	DICLOFENAC POTASSIUM TABLETS	Bryant Ranch Prepack	94898228-c595-4fd6-acc2-13dbdbde9c0e	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215750 application number: ANDA215750
Diclofenac Potassium	DICLOFENAC POTASSIUM TABLETS	Zydus Pharmaceuticals (USA) Inc.	1aa3d8d6-dd1c-46c7-96f9-2b5c9d72764a	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215750 application number: ANDA215750 ndc (product): 70710-1832
Diclofenac Potassium	DICLOFENAC POTASSIUM TABLETS	NIVAGEN PHARMACEUTICALS, INC.	1f06a404-07c3-4414-8c5c-357c01d6ccb3	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215750 application number: ANDA215750
Diclofenac Potassium	DICLOFENAC POTASSIUM TABLETS	NuCare Pharmaceuticals,Inc.	ffc41543-a353-cade-e053-6294a90a99fb	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215750 application number: ANDA215750
Diclofenac Potassium	DICLOFENAC POTASSIUM TABLETS	A-S Medication Solutions	5d37fc5a-7a2f-432e-b4e9-e00c246ce33c	2023-10-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215750 application number: ANDA215750

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60290-057	Diclofenac Potassium	Diclofenac Potassium Tablets	UMEDICA LABORATORIES PRIVATE LIMITED	ANDA	Current
60290-057	Diclofenac Potassium	Diclofenac Potassium Tablets	UMEDICA LABORATORIES PRIVATE LIMITED	ANDA	Current
70710-1832	Diclofenac Potassium	Diclofenac Potassium Tablets	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1832	Diclofenac Potassium	Diclofenac Potassium Tablets	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1832	Diclofenac Potassium	Diclofenac Potassium Tablets	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current