Application 078284

Type: ANDA
Sponsor: ORCHID HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	TABLET;ORAL	EQ 25MG BASE	No	No
002	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	TABLET;ORAL	EQ 50MG BASE	No	No
003	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	TABLET;ORAL	EQ 100MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078284-001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10
A078284-002	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10
A078284-003	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078284-001	AB
A078284-002	AB
A078284-003	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 4 · 123 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	A078284-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078284-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078284-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078284-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078284-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078284-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078284-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078284-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078284-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078284-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078284-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078284-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078284-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078284-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078284-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078284-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078284-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078284-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078284-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078284-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078284-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078284-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078284-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078284-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078284-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078284-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078284-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078284-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078284-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078284-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078284-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078284-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078284-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078284-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078284-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078284-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078284-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078284-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078284-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078284-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078284-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078284-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078284-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078284-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078284-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078284-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078284-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078284-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078284-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078284-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078284-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078284-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078284-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078284-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078284-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078284-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078284-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078284-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078284-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078284-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078284-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078284-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078284-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078284-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078284-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078284-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078284-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078284-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078284-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078284-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078284-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078284-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078284-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078284-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078284-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078284-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078284-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078284-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078284-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078284-001	AB	1	`8072bd15b7f6…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sumatriptan	SUMATRIPTAN	Bionpharma Inc.	e90b0eea-c424-4f00-98da-6ed6e80de1f6	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078284 application number: ANDA078284 ndc (product): 69452-345 ndc (product): 69452-346 ndc (product): 69452-344
Sumatriptan	SUMATRIPTAN	Preferred Pharmaceuticals Inc.	0b9a0ab5-d8bd-4cae-b86c-45740ee1015a	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078284 application number: ANDA078284
Sumatriptan	SUMATRIPTAN	Preferred Pharmaceuticals Inc.	ff08b9ee-03bf-4f5b-930e-233a3b8866af	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078284 application number: ANDA078284
Sumatriptan	SUMATRIPTAN	NuCare Pharmaceuticals,Inc.	082d05f6-3850-0fa2-e063-6294a90a0c66	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078284 application number: ANDA078284
Sumatriptan	SUMATRIPTAN	Direct_Rx	efb7ec4e-0a5d-2aae-e053-2a95a90aebf2	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078284 application number: ANDA078284 ndc (product): 72189-404
Sumatriptan	SUMATRIPTAN	Proficient Rx LP	85bf8e58-0984-427b-9ed4-7e0df4e444d2	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078284 application number: ANDA078284
Sumatriptan	SUMATRIPTAN	Advanced Rx Pharmacy of Tennessee, LLC	f27ca3c0-9de0-ff9c-e053-2a95a90ab894	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078284 application number: ANDA078284
Sumatriptan	SUMATRIPTAN	Advanced Rx of Tennessee, LLC	2aab8786-b225-833a-e063-6394a90ac7ae	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078284 application number: ANDA078284
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Direct_Rx	284ee7ac-759e-b592-e063-6394a90a78ba	2024-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078284 application number: ANDA078284
Sumatriptan	SUMATRIPTAN	A-S Medication Solutions	790acc89-81b3-4869-92e7-dc9f7fa6567b	2024-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078284 application number: ANDA078284

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-531	Sumatriptan	Sumatriptan	Northstar Rx LLC	ANDA	Current
16714-531	Sumatriptan	Sumatriptan	Northstar Rx LLC	ANDA	Current
16714-532	Sumatriptan	Sumatriptan	Northstar Rx LLC	ANDA	Current
16714-532	Sumatriptan	Sumatriptan	Northstar Rx LLC	ANDA	Current
16714-533	Sumatriptan	Sumatriptan	Northstar Rx LLC	ANDA	Current
16714-533	Sumatriptan	Sumatriptan	Northstar Rx LLC	ANDA	Current
42043-220	Sumatriptan	Sumatriptan	OrchidPharma Inc	ANDA	Current
42043-220	Sumatriptan	Sumatriptan	OrchidPharma Inc	ANDA	Current
42043-220	Sumatriptan	Sumatriptan	OrchidPharma Inc	ANDA	Current
42043-221	Sumatriptan	Sumatriptan	OrchidPharma Inc	ANDA	Current
42043-221	Sumatriptan	Sumatriptan	OrchidPharma Inc	ANDA	Current
42043-221	Sumatriptan	Sumatriptan	OrchidPharma Inc	ANDA	Current
42043-222	Sumatriptan	Sumatriptan	OrchidPharma Inc	ANDA	Current
42043-222	Sumatriptan	Sumatriptan	OrchidPharma Inc	ANDA	Current
42043-222	Sumatriptan	Sumatriptan	OrchidPharma Inc	ANDA	Current
53002-3562	Sumatriptan	Sumatriptan	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-918	Sumatriptan	Sumatriptan	Quality Care Products, LLC	ANDA	Current
55700-969	Sumatriptan	Sumatriptan	Quality Care Products, LLC	ANDA	Current
68071-2825	Sumatriptan	Sumatriptan	NuCare Pharmaceuticals,Inc.	ANDA	Current
69452-344	Sumatriptan	Sumatriptan	Bionpharma Inc.	ANDA	Current
69452-345	Sumatriptan	Sumatriptan	Bionpharma Inc.	ANDA	Current
69452-346	Sumatriptan	Sumatriptan	Bionpharma Inc.	ANDA	Current
72189-404	Imitrex	Sumatriptan	Direct_Rx	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31353	ORIG	2009-08-14