Application 087693

Type: ANDA
Sponsor: TERSERA THERAPS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERGOMAR	ERGOTAMINE TARTRATE	TABLET;SUBLINGUAL	2MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A087693-001	ERGOMAR	ERGOTAMINE TARTRATE	2MG	TABLET / SUBLINGUAL		RLD, RS	1983-02-24

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ergomar Sublingual	ERGOTAMINE TARTRATE	Pangea Pharmaceuticals LLC	a9582fdb-7ddd-4f69-aa7a-66247cdb8c92	2025-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087693 application number: ANDA087693

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10802-1202	Ergomar	Ergotamine Tartrate	Rosedale Therapeutics	ANDA	Current
70720-120	Ergomar	Ergotamine Tartrate	TerSera Therapeutics, LLC	ANDA	Current
70720-120	Ergomar	Ergotamine Tartrate	TerSera Therapeutics, LLC	ANDA	Current
70720-120	Ergomar	Ergotamine Tartrate	TerSera Therapeutics, LLC	ANDA	Current