Application 040510

Type: ANDA
Sponsor: HIKMA INTL PHARMS

Application Products#

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

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
A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	CAFFEINE; ERGOTAMINE TARTRATE	100MG;1MG	TABLET / ORAL			2004-09-17

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 1 of 2 · 41 observed 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
2026-02-19 14:30 UTC	2026-02	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL	AA	2004-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL	AA	2004-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL	AA	2004-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL	AA	2004-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040510-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		2004-09-17	`cb3db0bc1861…`

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	A040510-001	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A040510-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040510-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040510-001	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
ergotamine tartrate and caffeine	ERGOTAMINE TARTRATE AND CAFFEINE	Cintex Services, LLC	41f88ae7-c124-5b9c-e054-00144ff88e88	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ergotamine tartrate and caffeine

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-2120	ERGOTAMINE	ergotamine tartrate and caffeine	West-Ward Pharmaceutical Corp	ANDA	Current