Application 202091

Type: NDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUPRAX	CEFIXIME	FOR SUSPENSION;ORAL	500MG/5ML	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
N202091-001	SUPRAX	CEFIXIME	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N202091-001	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20

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	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202091-001	SUPRAX	500MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2013-02-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N202091-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202091-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202091-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202091-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202091-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202091-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202091-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202091-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202091-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202091-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202091-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202091-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202091-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202091-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202091-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202091-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202091-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202091-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202091-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202091-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202091-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202091-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202091-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202091-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202091-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202091-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202091-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202091-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202091-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202091-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202091-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202091-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202091-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202091-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202091-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202091-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202091-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202091-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202091-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202091-001	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202091-001	9233112	2028-12-14	U-1676	Drug product	2016-01-20	`e64feba35796…`

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27437-207	SUPRAX	cefixime	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-207	SUPRAX	cefixime	Lupin Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60755	SUPPL	2019-10-31
60727	SUPPL	2019-10-30
53567	SUPPL	2018-04-01
53527	SUPPL	2018-03-29
47596	SUPPL	2017-03-20
47579	SUPPL	2017-03-17
40114	SUPPL	2016-01-12
9956	SUPPL	2016-01-11
19057	SUPPL	2014-06-04
9955	SUPPL	2014-06-02
43382	ORIG	2014-01-08
24406	ORIG	2014-01-08
19056	ORIG	2013-02-21
9954	ORIG	2013-02-21