Home Applications 013718 Application 013718
Type NDA
Sponsor GEMINI LABS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OXANDRIN OXANDROLONE TABLET;ORAL 2.5MG Yes No 002 OXANDRIN OXANDROLONE TABLET;ORAL 10MG Yes No
Source provenance: Browse the complete Orange Book source catalog .
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 1 of 2 · 42 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 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 ea99ee380514…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N013718-001 OXANDRIN 2.5MG TABLET / ORAL RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N013718-002 OXANDRIN 10MG TABLET / ORAL RLD 2001-11-05 e64feba35796…
Documents# Document, Submission type, Date table Document Submission type Date 40692 SUPPL 2006-10-25 10835 SUPPL 2005-06-21 367 SUPPL 2005-06-21 33109 SUPPL 2003-06-10 10834 SUPPL 2003-06-10 12055 SUPPL 2003-05-29 33110 SUPPL 2003-05-28 12054 SUPPL 2001-11-05 366 SUPPL 2001-11-05