Application 065307

Type: ANDA
Sponsor: ORCHID HLTHCARE

Application Products#

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

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

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
A065307-002	CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL			2006-10-16
A065307-003	CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL			2006-10-16

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL		2006-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065307-002	CEFADROXIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-10-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065307-003	CEFADROXIL	EQ 500MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-10-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A065307-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065307-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065307-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065307-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065307-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065307-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065307-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065307-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065307-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065307-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065307-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065307-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065307-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065307-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065307-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065307-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065307-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065307-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065307-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065307-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065307-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065307-003	AB	1	`ea99ee380514…`

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefadroxil	CEFADROXIL	Proficient Rx LP	57eebea5-28b6-44a3-888b-76950f6038f4	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Redpharm Drug	4fb524c1-f985-2a8f-e063-6394a90aab7f	2026-04-18	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	REMEDYREPACK INC.	eb365f05-1c8f-4495-b443-abb0580b39fb	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Preferred Pharmaceuticals, Inc.	485bc35b-637a-426b-aaa2-023c664914ae	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Preferred Pharmaceuticals Inc.	41bc5f5a-5e1d-4cb6-a795-9f1756a8f074	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	RedPharm Drug, Inc.	97193a92-12ff-cfab-e053-2a95a90a9f14	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Redpharm Drug	1c50c0db-ca03-6217-e063-6294a90a89fa	2025-12-25	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Redpharm Drug	45ac01b1-b5b7-6fc1-e063-6394a90a271a	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	NuCare Pharmaceuticals,Inc.	7e931c7e-5ab6-c39c-e053-2a91aa0a59d9	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	PD-Rx Pharmaceuticals, Inc.	ab9cf28c-7c16-4bfa-879d-c360b4d1d5a6	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Lupin Pharmaceuticals, Inc.	5fe066ce-2f97-49d7-81bd-a672be1ebecd	2025-10-10	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Lupin Pharmaceuticals, Inc.	27009a05-4d2b-4618-be76-39f348240eda	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Bryant Ranch Prepack	caee9515-9a10-4020-af47-e9833aa69ef8	2025-06-20	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	PD-Rx Pharmaceuticals, Inc.	f5bbbf87-f059-4bbd-aea9-27d31462654f	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Direct_Rx	f6ddd84a-4a44-7035-e053-6294a90a6606	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
CEFADROXIL	CEFADROXIL	DIRECT RX	a7e74b63-9d5c-7baa-e053-2a95a90a98b2	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: CEFADROXIL
Cefadroxil	CEFADROXIL	Teva Pharmaceuticals USA, Inc.	bda86975-8c2f-4c4e-9a4c-a1a959f9336a	2024-12-30	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Teva Pharmaceuticals USA, Inc.	4674a05c-fdef-4737-a4b8-e3229bdada9d	2024-12-30	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Advanced Rx of Tennessee, LLC	205cb17b-6fbf-e147-e063-6294a90a608e	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil
Cefadroxil	CEFADROXIL	Direct_Rx	02566385-46f3-255a-e063-6294a90a1d1c	2024-06-26	Warnings, Adverse reactions	Name fallback brand name: Cefadroxil