Application 208303

Type: ANDA
Sponsor: ZYDUS PHARMS

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	250MCG	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
A208303-001	ROFLUMILAST	ROFLUMILAST	500MCG	TABLET / ORAL	AB		2022-02-10
A208303-002	ROFLUMILAST	ROFLUMILAST	250MCG	TABLET / ORAL	AB		2023-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208303-001	AB
A208303-002	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 · 53 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	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 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	A208303-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208303-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208303-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208303-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208303-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208303-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208303-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208303-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208303-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208303-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208303-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208303-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208303-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208303-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208303-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208303-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208303-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208303-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208303-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208303-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208303-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208303-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208303-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208303-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208303-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208303-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208303-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208303-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208303-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208303-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208303-001	AB	1	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208303-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208303-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208303-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208303-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208303-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208303-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208303-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208303-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208303-001	AB	1	`9b2671bbb829…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Roflumilast	ROFLUMILAST	Zydus Pharmaceuticals USA Inc.	84145572-f320-4c3f-ab29-bd9f6c18746c	2024-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208303 application number: ANDA208303 ndc (product): 68382-969
Roflumilast	ROFLUMILAST	Zydus Lifesciences Limited	e87287bd-eae3-46c3-9072-04800aeabf40	2024-08-12		Exact identifier application applno (ANDA): 208303 application number: ANDA208303 ndc (product): 70771-1674

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
68382-969	Roflumilast	Roflumilast	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1674	Roflumilast	Roflumilast	Cadila Healthcare Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72954	ORIG	2022-12-20