FDA.reportPublic FDA data

Application 091634

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALYACEN 1/35ETHINYL ESTRADIOL; NORETHINDRONETABLET;ORAL-280.035MG;1MGNoNo

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
A091634-001ALYACEN 1/35ETHINYL ESTRADIOL; NORETHINDRONE0.035MG;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
A091634-001AB

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 22:54:322026-06A091634-001ALYACEN 1/350.035MG;1MGTABLET / ORAL-28AB2012-01-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091634-001AB1a50c72e98297…

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 · 3 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): 091634
application number: ANDA091634
ndc (product): 68462-394
ALYACEN 1/35NORETHINDRONE AND ETHINYL ESTRADIOLProficient Rx LPfa32e05b-c86d-4743-aee5-be3fc515152b2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091634
application number: ANDA091634
ndc (product): 71205-547
ALYACEN 1/35NORETHINDRONE AND ETHINYL ESTRADIOLA-S Medication Solutionsa45ee86e-69ca-49a5-8990-5dde52d4a5222024-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091634
application number: ANDA091634
ndc (product): 50090-1477

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
50090-1477ALYACEN 1/35norethindrone and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-1477ALYACEN 1/35norethindrone and ethinyl estradiolA-S Medication SolutionsANDACurrent
53002-1780ALYACEN 1/35norethindrone and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
68462-394ALYACEN 1/35norethindrone and ethinyl estradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
70518-1212ALYACEN 1/35norethindrone and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
71205-547ALYACEN 1/35norethindrone and ethinyl estradiolProficient Rx LPANDACurrent