FDA.reportPublic FDA data

Application 203038

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL0.0025MG;0.5MGNoNo
002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL0.005MG;1MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.0025MG;0.5MGTABLET / ORALAB2015-04-02
A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.005MG;1MGTABLET / ORALAB2015-04-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203038-001AB
A203038-002AB

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 22:54:322026-06A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-02a50c72e98297…
2026-08-01 22:54:322026-06A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203038-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A203038-002AB1a50c72e98297…

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
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAcf549b5a-2707-4020-9f94-dab1260e16642026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203038
application number: ANDA203038
ndc (product): 68462-656
ndc (product): 68462-657

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68462-656Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-656Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-657Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-657Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent