Application 091036

Type: ANDA
Sponsor: HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML	No	No
002	CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	FOR SUSPENSION;ORAL	EQ 500MG BASE/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A091036-001	CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL			2012-11-28
A091036-002	CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL			2012-11-28

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 3 · 86 observed 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
2026-09-14 22:38:34	2026-08	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2012-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2012-11-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2012-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2012-11-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2012-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2012-11-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2012-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091036-001	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2012-11-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091036-002	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2012-11-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091036-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091036-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091036-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091036-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091036-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091036-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091036-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091036-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091036-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091036-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091036-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091036-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091036-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091036-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091036-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091036-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091036-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091036-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091036-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091036-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091036-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091036-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091036-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091036-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091036-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091036-002	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A091036-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A091036-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091036-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091036-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091036-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091036-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091036-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091036-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091036-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091036-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091036-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A091036-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091036-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A091036-002	AB	1	`3bdfa0b2c4d7…`

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 2 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefadroxil	CEFADROXIL	NuCare Pharmaceuticals,Inc.	a218d8d3-af90-4599-e053-2995a90a0ede	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	NuCare Pharmaceuticals,Inc.	8bdd68a4-4e2e-0170-e053-2a95a90adb78	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	NuCare Pharmaceuticals,Inc.	7278a39f-9de1-c9e2-e053-2a91aa0aea34	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Advanced Rx Pharmacy of Tennessee, LLC	1a50b564-b00f-58e4-e063-6294a90af2c6	2024-06-07	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	NuCare Pharmaceuticals,Inc.	16f3dd01-650a-2426-e063-6394a90a1b4b	2024-04-25	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Bryant Ranch Prepack	672519a7-11a1-4d8e-b2ca-dc9598c2f179	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Bryant Ranch Prepack	9c3bed82-6df0-4643-944a-a826f7dc018f	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Bryant Ranch Prepack	8cdaac56-b84a-4b6b-b94d-cab15d5961c5	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	A-S Medication Solutions	41ab333a-fafb-4647-844e-f3b2a76723cb	2024-02-15	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Advanced Rx Pharmacy of Tennessee, LLC	ec836a53-7ed1-79b9-e053-2a95a90a9c36	2024-02-09	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	NorthStar Rx LLC	30bb3686-87b4-4676-9ff5-e20deb8bff9d	2024-02-09	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Rising Pharma Holdings, Inc.	6e4111d3-f11b-403c-b340-b216022709df	2024-02-09	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Aurobindo Pharma Limited	776a8dbc-e68e-4732-acf4-0133dca0f54c	2024-02-09	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Rising Pharma Holdings, Inc.	74c99fd8-16d1-4d2c-9158-42ff5eed2b7c	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Aurobindo Pharma Limited	7bb90096-14d3-400e-94d3-048bff6b1292	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	NorthStar Rx LLC	17123057-58c7-401a-b87d-8c4c0764bbf6	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9766	Cefadroxil	Cefadroxil	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9766	Cefadroxil	Cefadroxil	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9766	Cefadroxil	Cefadroxil	West-Ward Pharmaceuticals	ANDA	Current
0143-9767	Cefadroxil	Cefadroxil	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9767	Cefadroxil	Cefadroxil	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9767	Cefadroxil	Cefadroxil	West-Ward Pharmaceuticals	ANDA	Current
68289-013	Cefadroxil	Cefadroxil	Jazeera Pharmaceutical	ANDA	Current
68289-014	Cefadroxil	Cefadroxil	Jazeera Pharmaceutical	ANDA	Current