Application 086557

Type: ANDA
Sponsor: COSETTE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIGERGOT	CAFFEINE; ERGOTAMINE TARTRATE	SUPPOSITORY;RECTAL	100MG;2MG	No	Yes

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

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
A086557-001	MIGERGOT	CAFFEINE; ERGOTAMINE TARTRATE	100MG;2MG	SUPPOSITORY / RECTAL		RLD, RS	1983-10-04

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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL		RLD, RS	1983-10-04	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
MIGERGOT	ERGOTAMINE TARTRATE AND CAFFEINE	Cosette Pharmaceuticals, Inc.	3a31ad0c-7bdd-544b-f5df-a99d04cf541c	2022-11-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086557 application number: ANDA086557 ndc (product): 0713-0166

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
0713-0166	MIGERGOT	Ergotamine Tartrate and Caffeine	G&W Laboratories, Inc.	ANDA	Current
0713-0166	MIGERGOT	Ergotamine Tartrate and Caffeine	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0166	MIGERGOT	Ergotamine Tartrate and Caffeine	Cosette Pharmaceuticals, Inc.	ANDA	Current
75987-090	Migergot	ergotamine tartrate and caffeine	Horizon Pharma Inc.	ANDA	Current