Home Applications 080767 Application 080767
Type ANDA
Sponsor IMPAX LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 METHYLTESTOSTERONE METHYLTESTOSTERONE TABLET;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A080767-002 METHYLTESTOSTERONE METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A080767-002 BP
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.
Product history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-09-29 23:25 UTC 2022-09 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join METHITEST METHYLTESTOSTERONE Amneal Pharmaceuticals of New York LLC 77bb4ef4-c10e-4acc-8225-651d003f4561 2025-05-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 080767 application number: ANDA080767 ndc (product): 0115-7037
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0115-7037 METHITEST METHYLTESTOSTERONE Impax Generics ANDA Current 0115-7037 METHITEST METHYLTESTOSTERONE Amneal Pharmaceuticals of New York LLC ANDA Current 0115-7037 METHITEST METHYLTESTOSTERONE Amneal Pharmaceuticals of New York LLC ANDA Current