FDA.reportPublic FDA data

Application 200383

Type
ANDA
Sponsor
NAARI PTE LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG;0.035MG;0.035MG;0.18MG;0.215MG;0.25MGNoNo

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
A200383-001NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATE0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28AB2015-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200383-001AB

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 22:54:322026-06A200383-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28AB2015-04-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A200383-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLNaari Pte Limitedb936a6fb-27ed-44de-9199-8c656bcd366e2024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200383
application number: ANDA200383
ndc (product): 79929-009

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-261Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolAkorn, Inc.ANDACurrent
17478-261Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolAkornANDACurrent
17478-261Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolAkorn, Inc.ANDACurrent
71205-170Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
71205-170Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
79929-009Norgestimate and ethinyl estradiolNorgestimate and ethinyl estradiolNaari Pte LimitedANDACurrent