Application 065080

Type: ANDA
Sponsor: RANBAXY LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DISPERMOX	AMOXICILLIN	TABLET, FOR SUSPENSION;ORAL	400MG	No	No
002	DISPERMOX	AMOXICILLIN	TABLET, FOR SUSPENSION;ORAL	200MG	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
A065080-001	DISPERMOX	AMOXICILLIN	400MG	TABLET, FOR SUSPENSION / ORAL			2003-08-11
A065080-002	DISPERMOX	AMOXICILLIN	200MG	TABLET, FOR SUSPENSION / ORAL			2003-08-11

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065080-001	DISPERMOX	400MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065080-002	DISPERMOX	200MG	TABLET, FOR SUSPENSION / ORAL	2003-08-11	`74a2ff9319b5…`

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 11 of 11 · 218 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	be1d1a44-7ef3-445d-9970-494921de4c9d	2023-03-18	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	d5eba477-e255-4d97-9e16-30543c298680	2023-03-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	77265bcd-c05d-443a-84c4-6e5ac75ee42c	2023-02-21	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	6c7bccff-00bf-46b0-a9ee-eb27d38d7377	2023-02-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	fe9e12de-9be9-4211-9a58-c7ecd9e838d5	2022-11-02	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	9cac2bf2-fb48-4e83-b953-61c4d55f7e19	2022-11-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	7f75de78-2228-48e0-8405-bf631ca431ab	2022-07-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	de792ac6-4b3d-4d34-8e50-030b5bd830d7	2022-06-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	756545f1-77af-49a0-a697-4cced31711d4	2022-06-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	e4bd448e-7911-4ae3-b136-a66d13e2ebed	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	23b7a1fe-4e23-44ec-bc51-5209427c88ce	2022-03-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	f27237d7-123a-44ba-97df-b2446a94e3e5	2021-11-24	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	e40f3e20-facf-46f4-89c7-3593bc27d0fc	2021-09-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	9528a356-4101-4be2-a7e2-b0659e169e1a	2021-01-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	ead1e453-af08-4a3b-8379-aa182dff514b	2020-09-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	7974a666-6d1d-446b-8ea5-f7145dc66358	2020-02-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	586a5911-e30b-40ed-a056-9e67920ca951	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	45a872b8-07b1-44fe-8b57-cc572d480e2e	2019-10-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22310	ORIG	2005-07-22