Application 208257

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROFLUMILAST	ROFLUMILAST	TABLET;ORAL	500MCG	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
A208257-001	ROFLUMILAST	ROFLUMILAST	500MCG	TABLET / ORAL			2018-07-13

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	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-07-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-07-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-07-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-07-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-07-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-07-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-07-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-07-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-07-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-07-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-07-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208257-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-07-13	`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	A208257-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208257-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208257-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208257-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208257-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208257-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208257-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208257-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208257-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208257-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208257-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208257-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208257-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208257-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208257-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208257-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208257-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208257-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208257-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208257-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208257-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208257-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208257-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208257-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208257-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208257-001	AB	1	`e64feba35796…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A208257-001	PC	2023-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208257-001	PC	2023-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208257-001	PC	2023-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208257-001	PC	2023-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208257-001	PC	2023-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208257-001	PC	2023-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208257-001	PC	2023-04-17	`3bdfa0b2c4d7…`

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Roflumilast	ROFLUMILAST	Jubilant Cadista Pharmaceuticals Inc.	aaa81c1b-f63d-4e61-8bfa-9d42d92043c7	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Roflumilast generic name: ROFLUMILAST
ZORYVE	ROFLUMILAST	Arcutis Biotherapeutics, Inc.	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	2026-07-02	Adverse reactions	Name fallback generic name: ROFLUMILAST
roflumilast	ROFLUMILAST	AvKARE	55009549-3f0c-1f58-e063-6294a90a6c03	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: roflumilast generic name: ROFLUMILAST
ZORYVE	ROFLUMILAST	Arcutis Biotherapeutics, Inc.	f9e0b4a9-a227-4947-b00c-41fb18d16589	2026-06-22	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
ROFLUMILAST	ROFLUMILAST	Amici Pharma Inc.	cb3781ff-5350-4f9a-b247-0b04eb0f2b92	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: ROFLUMILAST generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	Major Pharmaceuticals	ca22f3e0-6f33-4f1c-97e5-0c962891067a	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Roflumilast generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	MAJOR PHARMACEUTICALS	c51b80f3-a591-4db9-81b4-b91603e35d7c	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: Roflumilast generic name: ROFLUMILAST
ROFLUMILAST	ROFLUMILAST	Micro Labs Limited	dc2a689f-cfa4-4863-9623-a9813dcf86a9	2025-07-24	Warnings, Adverse reactions	Name fallback brand name: ROFLUMILAST generic name: ROFLUMILAST
ROFLUMILAST	ROFLUMILAST	Aurobindo Pharma Limited	7cb11d48-6bb9-437b-bc7f-382050a2d3e6	2025-05-27	Warnings, Adverse reactions	Name fallback brand name: ROFLUMILAST generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	Golden State Medical Supply, Inc.	30dd6eae-6435-cae1-e063-6294a90a003b	2025-03-21	Warnings, Adverse reactions	Name fallback brand name: Roflumilast generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	Ascend Laboratories, LLC	93d72a99-64dc-4fde-a5b8-78331fa60787	2025-03-13	Warnings, Adverse reactions	Name fallback brand name: Roflumilast generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	American Health Packaging	913f1b95-9c46-40d5-a6e9-cff2e5e07eaa	2024-11-21	Warnings, Adverse reactions	Name fallback brand name: Roflumilast generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	Novadoz Pharmaceuticals LLC	4d25f69c-58b7-4e2a-b835-4d0c76a83c7c	2024-08-27	Warnings, Adverse reactions	Name fallback brand name: Roflumilast generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	Zydus Pharmaceuticals USA Inc.	84145572-f320-4c3f-ab29-bd9f6c18746c	2024-08-16	Warnings, Adverse reactions	Name fallback brand name: Roflumilast generic name: ROFLUMILAST
ROFLUMILAST	ROFLUMILAST	Bryant Ranch Prepack	fa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f72	2024-08-15	Warnings, Adverse reactions	Name fallback brand name: ROFLUMILAST generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	Zydus Lifesciences Limited	e87287bd-eae3-46c3-9072-04800aeabf40	2024-08-12		Name fallback brand name: Roflumilast generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	Camber Pharmaceuticals, Inc.	f25a0230-3cf6-4366-bebe-0ea5ff8de5ab	2023-04-28	Warnings, Adverse reactions	Name fallback brand name: Roflumilast generic name: ROFLUMILAST
ROFLUMILAST	ROFLUMILAST	Solco Healthcare US, LLC.	4251c764-7224-4f94-9de7-b6c76cb1f5cd	2022-05-10	Warnings, Adverse reactions	Name fallback brand name: ROFLUMILAST generic name: ROFLUMILAST
Daliresp	ROFLUMILAST	AstraZeneca Pharmaceuticals LP	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	2020-03-12	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1905	Roflumilast	Roflumilast	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1905	Roflumilast	Roflumilast	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48651	ORIG	2017-06-06