FDA.reportPublic FDA data

Application 091636

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALYACEN 7/7/7ETHINYL ESTRADIOL; NORETHINDRONETABLET;ORAL-280.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MGNoNo
002ALYACEN 777NORETHINDRONE; ETHINYL ESTRADIOLTABLET; ORAL0.75MG; 0.035MGNoNo
003ALYACEN 777NORETHINDRONE; ETHINYL ESTRADIOLTABLET; ORAL1MG; 0.035MGNoNo

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
A091636-001ALYACEN 7/7/7ETHINYL ESTRADIOL; NORETHINDRONE0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MGTABLET / ORAL-28AB2012-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091636-001AB

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 22:54:322026-06A091636-001ALYACEN 7/7/70.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MGTABLET / ORAL-28AB2012-01-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091636-001AB1a50c72e98297…

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
ALYACEN 1/35NORETHINDRONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA5c02b4d3-1e2f-439a-ae45-02304ee190d12026-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091636
application number: ANDA091636
ndc (product): 68462-556

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1478ALYACEN 7/7/7norethindrone and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-1478ALYACEN 7/7/7norethindrone and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-1478ALYACEN 7/7/7norethindrone and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-1478ALYACEN 7/7/7norethindrone and ethinyl estradiolA-S Medication SolutionsANDACurrent
53002-1734ALYACEN 7/7/7norethindrone and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1734ALYACEN 7/7/7norethindrone and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
68462-556ALYACEN 7/7/7norethindrone and ethinyl estradiolGlenmark Pharmaceuticals Inc., USAANDACurrent