FDA.reportPublic FDA data

Application 201088

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIENVAETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.02MG;0.1MGNoNo

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
A201088-001VIENVAETHINYL ESTRADIOL; LEVONORGESTREL0.02MG;0.1MGTABLET / ORAL-28AB12015-05-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201088-001AB1

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 22:54:322026-06A201088-001VIENVA0.02MG;0.1MGTABLET / ORAL-28AB12015-05-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201088-001AB11a50c72e98297…

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
VIENVA TMLEVONORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsf6825c1a-ba78-47aa-9622-12e59517ab1a2026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201088
application number: ANDA201088
ndc (product): 50090-5580
Vienva TMLEVONORGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack8b1b92f7-b736-436d-b06d-1fedeb9704082024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201088
application number: ANDA201088
ndc (product): 63629-2344
VienvaLEVONORGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.58ea31df-f9cf-7d00-c2db-0529fb9a3e532024-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201088
application number: ANDA201088
ndc (product): 70700-118

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0254-2032OrsythiaLevonorgestrel and Ethinyl EstradiolPar Pharmaceutical, Inc.ANDACurrent
0254-2032OrsythiaLevonorgestrel and Ethinyl EstradiolPar Pharmaceutical, Inc.ANDACurrent
0781-5575Vienva TMLevonorgestrel and Ethinyl EstradiolSandoz IncANDACurrent
50090-4303OrsythiaLevonorgestrel and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50090-5580Vienva TMLevonorgestrel and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
53002-3647OrsythiaLevonorgestrel and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
63629-2344Vienva TMLevonorgestrel and Ethinyl EstradiolBryant Ranch PrepackANDACurrent
63629-2344Vienva TMLevonorgestrel and Ethinyl EstradiolBryant Ranch PrepackANDACurrent
63629-2344Vienva TMLevonorgestrel and Ethinyl EstradiolBryant Ranch PrepackANDACurrent
70518-1325Vienva TMLevonorgestrel and Ethinyl EstradiolREMEDYREPACK INC.ANDACurrent
70518-1325Vienva TMLevonorgestrel and Ethinyl EstradiolREMEDYREPACK INC.ANDACurrent
70700-118Vienva TMLevonorgestrel and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-118Vienva TMLevonorgestrel and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-118Vienva TMLevonorgestrel and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-118Vienva TMLevonorgestrel and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-118Vienva TMLevonorgestrel and Ethinyl EstradiolXiromed, LLC.ANDACurrent