FDA.reportPublic FDA data

Application 091452

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MARLISSAETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.03MG;0.15MGNoNo

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
A091452-001MARLISSAETHINYL ESTRADIOL; LEVONORGESTREL0.03MG;0.15MGTABLET / ORAL-28AB2012-02-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091452-001AB

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 22:54:322026-06A091452-001MARLISSA0.03MG;0.15MGTABLET / ORAL-28AB2012-02-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091452-001AB1a50c72e98297…

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
MARLISSALEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA9379d99e-c416-4dab-a817-1c110e0d4b932026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091452
application number: ANDA091452
ndc (product): 68462-388

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1392MARLISSALevonorgestrel and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50090-1392MARLISSALevonorgestrel and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
68462-388MARLISSALevonorgestrel and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-388MARLISSALevonorgestrel and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-388MARLISSALevonorgestrel and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-388MARLISSALevonorgestrel and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-388MARLISSALevonorgestrel and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-388MARLISSALevonorgestrel and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-6339MARLISSALevonorgestrel and Ethinyl EstradiolPreferreed Pharmaceuticals Inc.ANDACurrent
68788-6339MARLISSALevonorgestrel and Ethinyl EstradiolPreferreed Pharmaceuticals Inc.ANDACurrent
68788-6339MARLISSALevonorgestrel and Ethinyl EstradiolPreferreed Pharmaceuticals Inc.ANDACurrent