Application 065130

Type: ANDA
Sponsor: LUPIN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUPRAX	CEFIXIME	TABLET;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065130-001	SUPRAX	CEFIXIME	400MG	TABLET / ORAL			2004-02-12

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065130-001	SUPRAX	400MG	TABLET / ORAL	RS	2004-02-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065130-001	SUPRAX	400MG	TABLET / ORAL	RS	2004-02-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065130-001	SUPRAX	400MG	TABLET / ORAL	RS	2004-02-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065130-001	SUPRAX	400MG	TABLET / ORAL	RS	2004-02-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065130-001	SUPRAX	400MG	TABLET / ORAL		2004-02-12	`cb3db0bc1861…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CEFIXIME	CEFIXIME	REMEDYREPACK INC.	3194433c-c04e-442b-9668-fbeb0a15bac7	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: CEFIXIME
CEFIXIME	CEFIXIME	REMEDYREPACK INC.	d6718f02-8eea-4c2f-9aa2-65121d9a6e4c	2026-07-28	Warnings, Adverse reactions	Name fallback generic name: CEFIXIME
Cefixime	CEFIXIME	Rising Pharma Holdings, Inc.	b5a3c547-3bc7-4856-af9c-1bead294f5d9	2026-04-06	Warnings, Adverse reactions	Name fallback generic name: CEFIXIME
Cefixime	CEFIXIME	Aurobindo Pharma Limited	9cdb156f-7a99-413e-b49a-ffafaf9e93fe	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: CEFIXIME
Cefixime 400 mg	CEFIXIME	Health Department, Oklahoma State	f0fdb14b-e4fb-707e-e053-2a95a90a9049	2025-12-20	Warnings	Name fallback generic name: CEFIXIME
CEFIXIME	CEFIXIME	Lupin Pharmaceuticals, Inc.	6d68dbd9-7d75-4ff1-91db-79ff8ae879ec	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: CEFIXIME
Cefixime	CEFIXIME	Aurobindo Pharma Limited	068e6edd-a5fe-40d8-8dcf-ac82b78dced4	2024-02-14	Warnings, Adverse reactions	Name fallback generic name: CEFIXIME
CEFIXIME	CEFIXIME	Ascend Laboratories, LLC	6f1df975-f825-4301-87da-d7eba56a6890	2022-05-31	Warnings, Adverse reactions	Name fallback generic name: CEFIXIME

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
27437-201	SUPRAX	cefixime	Lupin Pharmaceuticals, Inc.	ANDA	Current
27437-201	SUPRAX	cefixime	Lupin Pharmaceuticals, Inc.	ANDA	Current
54348-797	SUPRAX	CEFIXIME	PharmPak, Inc.	ANDA	Current
54348-797	SUPRAX	CEFIXIME	PharmPak, Inc.	ANDA	Current