Application 208256

Type: ANDA
Sponsor: MSN LABORATORIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROFLUMILAST	ROFLUMILAST	TABLET;ORAL	500MCG	No	No
002	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208256-001	ROFLUMILAST	ROFLUMILAST	250MCG	TABLET / ORAL	AB		2022-09-07
A208256-002	ROFLUMILAST	ROFLUMILAST	500MCG	TABLET / ORAL	AB		2022-09-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A208256-001	AB
A208256-002	AB

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 · 54 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	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208256-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2022-09-07	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208256-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-09-07	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208256-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208256-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208256-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208256-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208256-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208256-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208256-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208256-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208256-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208256-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208256-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208256-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208256-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208256-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208256-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208256-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208256-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208256-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208256-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208256-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208256-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208256-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208256-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208256-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208256-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208256-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208256-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208256-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208256-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208256-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208256-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208256-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208256-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208256-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208256-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208256-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208256-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208256-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208256-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208256-002	AB	1	`a67488948f0b…`

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	A208256-001	PC	2023-04-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208256-001	PC	2023-04-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208256-001	PC	2023-04-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208256-001	PC	2023-04-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208256-001	PC	2023-04-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208256-001	PC	2023-04-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208256-001	PC	2023-04-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208256-001	PC	2023-04-18	`3a93d1ddd44b…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Roflumilast	ROFLUMILAST	Major Pharmaceuticals	ca22f3e0-6f33-4f1c-97e5-0c962891067a	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208256 application number: ANDA208256
Roflumilast	ROFLUMILAST	MAJOR PHARMACEUTICALS	c51b80f3-a591-4db9-81b4-b91603e35d7c	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208256 application number: ANDA208256
Roflumilast	ROFLUMILAST	Novadoz Pharmaceuticals LLC	4d25f69c-58b7-4e2a-b835-4d0c76a83c7c	2024-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208256 application number: ANDA208256 ndc (product): 72205-200 ndc (product): 72205-201

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
72205-200	Roflumilast	Roflumilast	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-201	Roflumilast	Roflumilast	Novadoz Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54445	ORIG	2018-06-05