Application 207581

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AUROVELA 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL-21	0.03MG;1.5MG	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
A207581-001	AUROVELA 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET / ORAL-21	AB		2017-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207581-001	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	A207581-001	AUROVELA 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB		2017-06-26	`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	A207581-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aurovela 1.5/30	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Aurobindo Pharma Limited	b146e49c-a0fc-4f3d-9ad6-99e8257fa139	2023-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207581 application number: ANDA207581 ndc (product): 65862-935

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65862-935	Aurovela 1.5/30	Norethindrone Acetate and Ethinyl Estradiol	Aurobindo Pharma Limited	ANDA	Current
65862-935	Aurovela 1.5/30	Norethindrone Acetate and Ethinyl Estradiol	Aurobindo Pharma Limited	ANDA	Current
65862-935	Aurovela 1.5/30	Norethindrone Acetate and Ethinyl Estradiol	Aurobindo Pharma Limited	ANDA	Current
65862-935	Aurovela 1.5/30	Norethindrone Acetate and Ethinyl Estradiol	Aurobindo Pharma Limited	ANDA	Current
65862-935	Aurovela 1.5/30	Norethindrone Acetate and Ethinyl Estradiol	Aurobindo Pharma Limited	ANDA	Current
65862-935	Aurovela 1.5/30	Norethindrone Acetate and Ethinyl Estradiol	Aurobindo Pharma Limited	ANDA	Current
65862-935	Aurovela 1.5/30	Norethindrone Acetate and Ethinyl Estradiol	Aurobindo Pharma Limited	ANDA	Current