Application 208213

Type: ANDA
Sponsor: HETERO LABS LTD III

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
A208213-001	ROFLUMILAST	ROFLUMILAST	500MCG	TABLET / ORAL	AB		2018-11-23
A208213-002	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
A208213-001	AB
A208213-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A208213-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB		2018-11-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208213-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB		2023-04-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A208213-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208213-002	AB	1	`a50c72e98297…`

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	American Health Packaging	913f1b95-9c46-40d5-a6e9-cff2e5e07eaa	2024-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208213 application number: ANDA208213
Roflumilast	ROFLUMILAST	Camber Pharmaceuticals, Inc.	f25a0230-3cf6-4366-bebe-0ea5ff8de5ab	2023-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208213 application number: ANDA208213 ndc (product): 31722-623

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
31722-623	Roflumilast	Roflumilast	Camber Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49691	ORIG	2017-09-07