Application 213650

Type: ANDA
Sponsor: PERRIGO UK FINCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUMATRIPTAN	SUMATRIPTAN	SPRAY;NASAL	5MG/SPRAY	No	No

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2021-03-12 10:30 UTC	2021-03	A213650-001	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213650-001	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213650-001	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	A213650-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213650-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213650-001	AB	1	`c0c555d07b60…`

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	SUMATRIPTAN	Padagis Israel Pharmaceuticals Ltd	6d521807-e5ce-498d-a224-5534c5ea61fa	2026-01-26	Warnings, Adverse reactions	Exact identifier ndc (product): 45802-619
SUMATRIPTAN	SUMATRIPTAN	Bryant Ranch Prepack	c7a5deb9-5de4-4a70-bb87-a40084b46f48	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213650 application number: ANDA213650 ndc (product): 63629-8701

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-619	SUMATRIPTAN	sumatriptan	Perrigo New York Inc	ANDA	Current
63629-8701	SUMATRIPTAN	sumatriptan	Bryant Ranch Prepack	ANDA	Current
63629-8701	SUMATRIPTAN	sumatriptan	Bryant Ranch Prepack	ANDA	Current