FDA.reportPublic FDA data

Application 208612

Type
NDA
Sponsor
AVION PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BALCOLTRAETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL0.02MG;0.1MGYesYes

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
N208612-001BALCOLTRAETHINYL ESTRADIOL; LEVONORGESTREL0.02MG;0.1MGTABLET / ORALAB3RLD, RS2018-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N208612-001AB3

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208612-00178380422027-06-01U-3251Drug substance2021-11-30

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 22:54:322026-06N208612-001BALCOLTRA0.02MG;0.1MGTABLET / ORALAB3RLD, RS2018-01-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N208612-001AB31a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N208612-00178380422027-06-01U-3251Drug substance2021-11-30a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levonorgestrel and ethinyl estradiolLEVONORGESTREL AND ETHINYL ESTRADIOLAcella Pharmaceuticals167b12a0-cdff-4081-a0a4-164482c239fa2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 208612
application number: NDA208612
ndc (product): 42192-623
BalcoltraLEVONORGESTREL AND ETHINYL ESTRADIOLAvion Pharmaceuticals752ab698-4b48-4614-8016-d1d33ee7c0072025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 208612
application number: NDA208612
ndc (product): 75854-602

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42192-623levonorgestrel and ethinyl estradiollevonorgestrel and ethinyl estradiolAcella PharmaceuticalsNDACurrent
75854-602Balcoltralevonorgestrel and ethinyl estradiolAvion PharmaceuticalsNDACurrent
75854-602Balcoltralevonorgestrel and ethinyl estradiolAvion PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70972SUPPL2022-05-04
70953SUPPL2022-05-03
56741ORIG2018-12-14
51029ORIG2018-01-11
51026ORIG2018-01-11