Application 209170

Type: ANDA
Sponsor: ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	TABLET;ORAL-28	0.15MG,N/A;0.02MG,0.01MG	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
A209170-001	DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET / ORAL-28	AB		2017-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209170-001	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	A209170-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET / ORAL-28	AB		2017-06-05	`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	A209170-001	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
desogestrel and ethinyl estradiol and ethinyl estradiol	DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	Apotex Corp.	5a179f7b-a718-494f-8c97-ece34f356ca7	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209170 application number: ANDA209170
desogestrel and ethinyl estradiol and ethinyl estradiol	DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	Naari Pte. Limited	f8961550-d103-8ee6-e053-6294a90a7571	2024-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209170 application number: ANDA209170