Application 077696

Type: ANDA
Sponsor: CHARTWELL MOLECULAR

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog.

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 3 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Asclemed USA, Inc.	b16886d0-224b-4d83-85c4-bc3eb3606c17	2020-10-24	Warnings, Adverse reactions	Name fallback brand name: Sumatriptan Succinate generic name: SUMATRIPTAN SUCCINATE
sumatriptan succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	d556563f-ad71-45c1-829a-cc11983bce0c	2020-03-01	Warnings, Adverse reactions	Name fallback brand name: sumatriptan succinate generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	68daf82a-334e-43ca-b4bb-5c66a82f52c8	2020-02-01	Warnings, Adverse reactions	Name fallback brand name: Sumatriptan Succinate generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	77a41cca-02d2-4b84-975e-d1925f0fca80	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Sumatriptan Succinate generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	d9c78ac5-7328-4204-8f66-96606d7db5c3	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Sumatriptan Succinate generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	44d6d757-489c-4262-a518-af8c470734d6	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: Sumatriptan Succinate generic name: SUMATRIPTAN SUCCINATE

Reported adverse events (FAERS/openFDA)#

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