Application 040475

Type: ANDA
Sponsor: PADDOCK LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	INJECTABLE;INJECTION	1MG/ML	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
A040475-001	DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION			2003-04-28

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	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040475-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2003-04-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040475-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040475-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040475-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040475-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040475-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040475-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040475-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040475-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040475-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040475-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040475-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040475-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040475-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040475-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040475-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040475-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040475-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040475-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040475-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040475-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040475-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040475-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040475-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040475-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040475-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040475-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040475-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040475-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040475-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040475-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040475-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040475-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040475-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040475-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040475-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040475-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040475-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040475-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040475-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040475-001	AP	1	`cb3db0bc1861…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATZUMI	DIHYDROERGOTAMINE MESYLATE	Satsuma Pharmaceuticals, Inc.	0982a44a-dc0c-75c0-e063-6394a90a6d6c	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine Mesylate	DIHYDROERGOTAMINE MESYLATE	Milla Pharmaceuticals Inc.	b464a64d-b150-4f6b-b3df-e486a41294d7	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dihydroergotamine Mesylate generic name: DIHYDROERGOTAMINE MESYLATE
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	Somerset Therapeutics, LLC	c8ffdc19-a90d-453c-b094-2347e116b405	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DIHYDROERGOTAMINE MESYLATE generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine mesylate	DIHYDROERGOTAMINE MESYLATE	Advagen Pharma Ltd	65f8c60d-9213-48ac-8233-acc5d44548f4	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dihydroergotamine mesylate generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine Mesylate	DIHYDROERGOTAMINE MESYLATE	Hikma Pharmaceuticals USA Inc.	9ffe6d5a-7348-0498-e053-2a95a90a97a8	2025-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dihydroergotamine Mesylate generic name: DIHYDROERGOTAMINE MESYLATE
BREKIYA	DIHYDROERGOTAMINE MESYLATE	Amneal Pharmaceuticals LLC	cdbf5619-767f-4165-aec2-17bdd92d9ca2	2025-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine mesylate	DIHYDROERGOTAMINE MESYLATE	Trifluent Pharma, LLC	4cb78f66-6ccf-4ac7-8599-e199f6995f05	2025-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dihydroergotamine mesylate generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine Mesylate	DIHYDROERGOTAMINE MESYLATE	Oceanside Pharmaceuticals	977de209-c53a-4cb4-9f3f-1e850600a9dc	2025-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dihydroergotamine Mesylate generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine Mesylate	DIHYDROERGOTAMINE MESYLATE	Provepharm Inc.	40b9ba9e-436e-444e-b078-01b12bb57ea7	2025-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dihydroergotamine Mesylate generic name: DIHYDROERGOTAMINE MESYLATE
Trudhesa	DIHYDROERGOTAMINE MESYLATE	Impel Pharmaceuticals LLC	b81397b0-910d-4eb4-8fee-a9a3c9d94d63	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine Mesylate	DIHYDROERGOTAMINE MESYLATE	Hikma Pharmaceuticals USA Inc.	3fbec3be-9f30-448e-89b9-367a55ed4c97	2024-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dihydroergotamine Mesylate generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine Mesylate	DIHYDROERGOTAMINE MESYLATE	Gland Pharma Limited	07a9112c-8c04-4849-8cb3-9463f58731d2	2023-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dihydroergotamine Mesylate generic name: DIHYDROERGOTAMINE MESYLATE
dihydroergotamine mesylate	DIHYDROERGOTAMINE MESYLATE	Baxter Healthcare Corporation	f87dcd07-90ef-4e37-853e-7a5911a038b1	2023-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: dihydroergotamine mesylate generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine Mesylate	DIHYDROERGOTAMINE MESYLATE	Hikma Pharmaceuticals USA Inc.	683ca944-efa7-4ca3-9cbe-cf0e7ffb1d64	2023-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dihydroergotamine Mesylate generic name: DIHYDROERGOTAMINE MESYLATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0574-0850	Dihydroergotamine Mesylate	Dihydroergotamine Mesylate	Paddock Laboratories, LLC.	ANDA	Current
0574-0850	Dihydroergotamine Mesylate	Dihydroergotamine Mesylate	Paddock Laboratories, LLC	ANDA	Current
0574-0850	Dihydroergotamine Mesylate	Dihydroergotamine Mesylate	Padagis US LLC	ANDA	Current
0574-0850	Dihydroergotamine Mesylate	Dihydroergotamine Mesylate	Padagis US LLC	ANDA	Current
0574-0851	dihydroergotamine mesylate	dihydroergotamine mesylate	Paddock Laboratories, LLC.	ANDA	Current
0574-0851	dihydroergotamine mesylate	dihydroergotamine mesylate	Paddock Laboratories, LLC.	ANDA	Current
0574-0851	dihydroergotamine mesylate	dihydroergotamine mesylate	Paddock Laboratories, LLC.	ANDA	Current
70529-030	Dromelate	Dihydroergotamine Mesylate	IT3 Medical LLC	ANDA	Current
70529-030	Dromelate	Dihydroergotamine Mesylate	IT3 Medical LLC	ANDA	Current
70529-030	Dromelate	Dihydroergotamine Mesylate	IT3 Medical LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42630	ORIG	2005-07-22