Application 077744

Type: ANDA
Sponsor: MYLAN

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 42.

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
A077744-001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10
A077744-002	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10
A077744-003	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
A077744-001	AB
A077744-002	AB
A077744-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A077744-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077744-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077744-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077744-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077744-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077744-003	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	A077744-001	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	A077744-002	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	A077744-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077744-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077744-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077744-003	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	A077744-001	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	A077744-002	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	A077744-003	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	A077744-001	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	A077744-002	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	A077744-003	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	A077744-001	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	A077744-002	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	A077744-003	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	A077744-001	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	A077744-002	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	A077744-003	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	A077744-001	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	A077744-002	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	A077744-003	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	A077744-001	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	A077744-002	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	A077744-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077744-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077744-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077744-003	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	A077744-001	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	A077744-002	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	A077744-003	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	A077744-001	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	A077744-002	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	A077744-003	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	A077744-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A077744-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077744-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077744-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077744-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077744-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077744-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077744-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077744-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077744-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077744-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077744-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077744-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077744-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077744-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077744-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077744-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077744-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077744-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077744-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077744-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077744-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077744-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077744-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077744-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077744-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077744-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077744-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077744-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077744-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077744-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077744-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077744-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077744-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077744-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077744-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077744-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077744-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077744-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077744-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077744-001	AB	1	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Golden State Medical Supply, Inc.	1bf70380-8272-4c0d-8841-d39ef2772351	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077744 application number: ANDA077744 ndc (product): 51407-011 ndc (product): 51407-012 ndc (product): 51407-013
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Mylan Pharmaceuticals Inc.	1d2cd01c-05e7-44cf-a71d-0f474e826b7e	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077744 application number: ANDA077744 ndc (product): 0378-5631 ndc (product): 0378-5632 ndc (product): 0378-5630

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5630	Sumatriptan Succinate	sumatriptan succinate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5630	Sumatriptan Succinate	sumatriptan succinate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5630	Sumatriptan Succinate	sumatriptan succinate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5630	Sumatriptan Succinate	sumatriptan succinate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5630	Sumatriptan Succinate	sumatriptan succinate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5631	Sumatriptan Succinate	sumatriptan succinate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5631	Sumatriptan Succinate	sumatriptan succinate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5631	Sumatriptan Succinate	sumatriptan succinate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5631	Sumatriptan Succinate	sumatriptan succinate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5631	Sumatriptan Succinate	sumatriptan succinate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5632	Sumatriptan Succinate	sumatriptan succinate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5632	Sumatriptan Succinate	sumatriptan succinate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5632	Sumatriptan Succinate	sumatriptan succinate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5632	Sumatriptan Succinate	sumatriptan succinate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5632	Sumatriptan Succinate	sumatriptan succinate	Mylan Pharmaceuticals Inc.	ANDA	Current
51407-011	Sumatriptan Succinate	sumatriptan succinate	GSMS, Incorporated	ANDA	Current
51407-011	Sumatriptan Succinate	sumatriptan succinate	Golden State Medical Supply, Inc.	ANDA	Current
51407-011	Sumatriptan Succinate	sumatriptan succinate	Golden State Medical Supply, Inc.	ANDA	Current
51407-011	Sumatriptan Succinate	sumatriptan succinate	Golden State Medical Supply, Inc.	ANDA	Current
51407-011	Sumatriptan Succinate	sumatriptan succinate	Golden State Medical Supply, Inc.	ANDA	Current
51407-012	Sumatriptan Succinate	sumatriptan succinate	GSMS, Incorporated	ANDA	Current
51407-012	Sumatriptan Succinate	sumatriptan succinate	Golden State Medical Supply, Inc.	ANDA	Current
51407-012	Sumatriptan Succinate	sumatriptan succinate	Golden State Medical Supply, Inc.	ANDA	Current
51407-012	Sumatriptan Succinate	sumatriptan succinate	Golden State Medical Supply, Inc.	ANDA	Current
51407-012	Sumatriptan Succinate	sumatriptan succinate	Golden State Medical Supply, Inc.	ANDA	Current
51407-013	Sumatriptan Succinate	sumatriptan succinate	GSMS, Incorporated	ANDA	Current
51407-013	Sumatriptan Succinate	sumatriptan succinate	Golden State Medical Supply, Inc.	ANDA	Current
51407-013	Sumatriptan Succinate	sumatriptan succinate	Golden State Medical Supply, Inc.	ANDA	Current
51407-013	Sumatriptan Succinate	sumatriptan succinate	Golden State Medical Supply, Inc.	ANDA	Current
51407-013	Sumatriptan Succinate	sumatriptan succinate	Golden State Medical Supply, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31286	ORIG	2009-08-14