FDA.reportPublic FDA data

Application 207067

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESOGESTREL AND ETHINYL ESTRADIOLDESOGESTREL; ETHINYL ESTRADIOLTABLET;ORAL-280.15MG;0.03MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207067-001DESOGESTREL AND ETHINYL ESTRADIOLDESOGESTREL; ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28AB2018-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207067-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A207067-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28AB2018-09-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207067-001AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
desogestrel and ethinyl estradiolDESOGESTREL AND ETHINYL ESTRADIOLApotex Corp.9bb13b85-5d54-4689-b915-50b1da3a525b2025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207067
application number: ANDA207067
desogestrel and ethinyl estradiolDESOGESTREL AND ETHINYL ESTRADIOLNaari Pte Limitedf0323be5-9654-4236-8164-230f51a028cd2024-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207067
application number: ANDA207067
ndc (product): 79929-006

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
79929-006desogestrel and ethinyl estradioldesogestrel and ethinyl estradiolNaari Pte LimitedANDACurrent