Application 203195

Type: NDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUPRAX	CEFIXIME	CAPSULE;ORAL	400MG	Yes	Yes

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

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
N203195-001	SUPRAX	CEFIXIME	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N203195-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2012-06-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203195-001	SUPRAX	400MG	CAPSULE / ORAL		RLD	2012-06-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203195-001	SUPRAX	400MG	CAPSULE / ORAL		RLD	2012-06-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203195-001	SUPRAX	400MG	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2012-06-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL		RLD	2012-06-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203195-001	SUPRAX	400MG	CAPSULE / ORAL		RLD	2012-06-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203195-001	SUPRAX	400MG	CAPSULE / ORAL		RLD	2012-06-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203195-001	SUPRAX	400MG	CAPSULE / ORAL		RLD	2012-06-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203195-001	SUPRAX	400MG	CAPSULE / ORAL		RLD	2012-06-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203195-001	SUPRAX	400MG	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203195-001	SUPRAX	400MG	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203195-001	SUPRAX	400MG	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203195-001	SUPRAX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, RS	2012-06-01	`e64feba35796…`

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	N203195-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203195-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203195-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203195-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203195-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203195-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203195-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203195-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203195-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203195-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203195-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203195-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203195-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203195-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203195-001	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	N203195-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N203195-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203195-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203195-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203195-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203195-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203195-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203195-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203195-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203195-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203195-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203195-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203195-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203195-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203195-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203195-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203195-001	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 · 2 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	Exact identifier application applno (NDA): 203195 application number: NDA203195 ndc (product): 70518-3221
CEFIXIME	CEFIXIME	Lupin Pharmaceuticals, Inc.	6d68dbd9-7d75-4ff1-91db-79ff8ae879ec	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203195 application number: NDA203195 ndc (product): 68180-423

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27437-208	SUPRAX	cefixime	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-208	SUPRAX	cefixime	Lupin Pharmaceuticals, Inc.	NDA	Current
43063-537	SUPRAX	cefixime	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-537	SUPRAX	cefixime	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-537	SUPRAX	cefixime	PD-Rx Pharmaceuticals, Inc.	NDA	Current
68180-423	CEFIXIME	CEFIXIME	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-423	CEFIXIME	CEFIXIME	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
70518-1020	SUPRAX	cefixime	REMEDYREPACK INC.	NDA	Current
70518-2006	SUPRAX	cefixime	REMEDYREPACK INC.	NDA	Current
70518-3221	CEFIXIME	CEFIXIME	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-3221	CEFIXIME	CEFIXIME	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-3221	CEFIXIME	CEFIXIME	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70934-079	SUPRAX	cefixime	Denton Pharma, Inc.	NDA	Current
70934-079	SUPRAX	cefixime	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82413	SUPPL	2025-06-02
82315	SUPPL	2025-05-27
73444	SUPPL	2023-02-09
53566	SUPPL	2018-04-01
53526	SUPPL	2018-03-29
47597	SUPPL	2017-03-20
47578	SUPPL	2017-03-17
40273	SUPPL	2016-01-12
10182	SUPPL	2016-01-11
19445	SUPPL	2013-04-01
44879	ORIG	2012-11-16
43424	ORIG	2012-11-16
10181	ORIG	2012-06-07
40272	ORIG	2012-06-05