Application 084294

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAFERGOT	CAFFEINE; ERGOTAMINE TARTRATE	TABLET;ORAL	100MG;1MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A084294-001	CAFERGOT	CAFFEINE; ERGOTAMINE TARTRATE	100MG;1MG	TABLET / ORAL		RLD, Approved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A084294-001	CAFERGOT	100MG;1MG	TABLET / ORAL	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084294-001	CAFERGOT	100MG;1MG	TABLET / ORAL	RLD, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A084294-001	CAFERGOT	100MG;1MG	TABLET / ORAL	RLD, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A084294-001	AA	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084294-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084294-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084294-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084294-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084294-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084294-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084294-001	AA	1	`ea99ee380514…`

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
Cafergot	ERGOTAMINE TARTRATE AND CAFFEINE	Trifluent Pharma, LLC	4db7eece-2eef-bc1b-e063-6394a90a98cb	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Cafergot

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-5405	Cafergot	Ergotamine Tartrate and Caffeine	Sandoz Inc	ANDA	Current
0781-5405	Cafergot	Ergotamine Tartrate and Caffeine	Sandoz Inc	ANDA	Current
0781-5405	Cafergot	Ergotamine Tartrate and Caffeine	Sandoz Inc	ANDA	Current