Application 065380

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUPRAX	CEFIXIME	TABLET, CHEWABLE;ORAL	100MG	No	No
002	SUPRAX	CEFIXIME	TABLET, CHEWABLE;ORAL	150MG	No	No
003	SUPRAX	CEFIXIME	TABLET, CHEWABLE;ORAL	200MG	No	Yes

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	Approval date
A065380-001	SUPRAX	CEFIXIME	100MG	TABLET, CHEWABLE / ORAL	2010-10-25
A065380-002	SUPRAX	CEFIXIME	150MG	TABLET, CHEWABLE / ORAL	2010-10-25
A065380-003	SUPRAX	CEFIXIME	200MG	TABLET, CHEWABLE / ORAL	2010-10-25

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065380-001	SUPRAX	100MG	TABLET, CHEWABLE / ORAL		2010-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065380-002	SUPRAX	150MG	TABLET, CHEWABLE / ORAL		2010-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065380-003	SUPRAX	200MG	TABLET, CHEWABLE / ORAL		2010-10-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065380-001	SUPRAX	100MG	TABLET, CHEWABLE / ORAL		2010-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065380-002	SUPRAX	150MG	TABLET, CHEWABLE / ORAL		2010-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065380-003	SUPRAX	200MG	TABLET, CHEWABLE / ORAL		2010-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065380-001	SUPRAX	100MG	TABLET, CHEWABLE / ORAL		2010-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065380-002	SUPRAX	150MG	TABLET, CHEWABLE / ORAL		2010-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065380-003	SUPRAX	200MG	TABLET, CHEWABLE / ORAL	RS	2010-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065380-001	SUPRAX	100MG	TABLET, CHEWABLE / ORAL		2010-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065380-002	SUPRAX	150MG	TABLET, CHEWABLE / ORAL		2010-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065380-003	SUPRAX	200MG	TABLET, CHEWABLE / ORAL	RS	2010-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065380-001	SUPRAX	100MG	TABLET, CHEWABLE / ORAL		2010-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065380-002	SUPRAX	150MG	TABLET, CHEWABLE / ORAL		2010-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065380-003	SUPRAX	200MG	TABLET, CHEWABLE / ORAL	RS	2010-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065380-001	SUPRAX	100MG	TABLET, CHEWABLE / ORAL		2010-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065380-002	SUPRAX	150MG	TABLET, CHEWABLE / ORAL		2010-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065380-003	SUPRAX	200MG	TABLET, CHEWABLE / ORAL	RS	2010-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065380-001	SUPRAX	100MG	TABLET, CHEWABLE / ORAL		2010-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065380-002	SUPRAX	150MG	TABLET, CHEWABLE / ORAL		2010-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065380-003	SUPRAX	200MG	TABLET, CHEWABLE / ORAL	RS	2010-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065380-001	SUPRAX	100MG	TABLET, CHEWABLE / ORAL		2010-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065380-002	SUPRAX	150MG	TABLET, CHEWABLE / ORAL		2010-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065380-003	SUPRAX	200MG	TABLET, CHEWABLE / ORAL	RS	2010-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065380-001	SUPRAX	100MG	TABLET, CHEWABLE / ORAL		2010-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065380-002	SUPRAX	150MG	TABLET, CHEWABLE / ORAL		2010-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065380-003	SUPRAX	200MG	TABLET, CHEWABLE / ORAL	RS	2010-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065380-001	SUPRAX	100MG	TABLET, CHEWABLE / ORAL		2010-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065380-002	SUPRAX	150MG	TABLET, CHEWABLE / ORAL		2010-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065380-003	SUPRAX	200MG	TABLET, CHEWABLE / ORAL	RS	2010-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065380-001	SUPRAX	100MG	TABLET, CHEWABLE / ORAL		2010-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065380-002	SUPRAX	150MG	TABLET, CHEWABLE / ORAL		2010-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065380-003	SUPRAX	200MG	TABLET, CHEWABLE / ORAL	RS	2010-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065380-001	SUPRAX	100MG	TABLET, CHEWABLE / ORAL		2010-10-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065380-002	SUPRAX	150MG	TABLET, CHEWABLE / ORAL		2010-10-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065380-003	SUPRAX	200MG	TABLET, CHEWABLE / ORAL	RS	2010-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065380-001	SUPRAX	100MG	TABLET, CHEWABLE / ORAL		2010-10-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065380-002	SUPRAX	150MG	TABLET, CHEWABLE / ORAL		2010-10-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065380-003	SUPRAX	200MG	TABLET, CHEWABLE / ORAL	RS	2010-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065380-001	SUPRAX	100MG	TABLET, CHEWABLE / ORAL		2010-10-25	`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 · 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
27437-203	SUPRAX	cefixime	Lupin Pharmaceuticals, Inc.	ANDA	Current
27437-203	SUPRAX	cefixime	Lupin Pharmaceuticals, Inc.	ANDA	Current
27437-205	SUPRAX	cefixime	Lupin Pharmaceuticals, Inc.	ANDA	Current
27437-205	SUPRAX	cefixime	Lupin Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8395	ORIG	2010-10-29