Home Applications 215888 Application 215888
Type NDA
Sponsor MYCOVIA PHARMACEUTICALS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VIVJOA OTESECONAZOLE CAPSULE; ORAL 150MG 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 N215888-001 VIVJOA OTESECONAZOLE 150MG CAPSULE / ORAL RLD, RS 2022-04-26
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215888-001 NCE 2027-04-26 N215888-001 GAIN 2032-04-26
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 155 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 62 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 VIVJOA OTESECONAZOLE Mycovia Pharmaceuticals, Inc. e21d5008-800e-4417-927f-14340341865f 2026-01-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 215888 application number: NDA215888 ndc (product): 74695-823
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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 74695-823 VIVJOA oteseconazole Mycovia Pharmaceuticals, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 78126 SUPPL 2024-04-12 78122 SUPPL 2024-04-11 71037 ORIG 2022-05-11 70840 ORIG 2022-04-28 70821 ORIG 2022-04-27