Home Applications 019781 Application 019781
Type NDA
Sponsor VIRTUS PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROMETRIUM PROGESTERONE CAPSULE;ORAL 100MG Yes No 002 PROMETRIUM PROGESTERONE CAPSULE;ORAL 200MG Yes Yes 003 PROMETRIUM PROGESTERONE CAPSULE;ORAL 300MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019781-001 PROMETRIUM PROGESTERONE 100MG CAPSULE / ORAL AB RLD 1998-05-14 N019781-002 PROMETRIUM PROGESTERONE 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 N019781-003 PROMETRIUM PROGESTERONE 300MG CAPSULE / ORAL 1999-10-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 4 · 123 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 2026-02-19 14:30 UTC 2026-02 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50090-3240 Progesterone Progesterone A-S Medication Solutions NDA Current 50090-3240 Progesterone Progesterone A-S Medication Solutions NDA Current 50090-3240 Progesterone Progesterone A-S Medication Solutions NDA Current 63629-7475 Progesterone Progesterone Bryant Ranch Prepack NDA Current 63629-7475 Progesterone Progesterone Bryant Ranch Prepack NDA Current 63629-7475 Progesterone Progesterone Bryant Ranch Prepack NDA Current 63629-8530 Progesterone Progesterone Bryant Ranch Prepack NDA Current 63629-8530 Progesterone Progesterone Bryant Ranch Prepack NDA Current 69543-372 Prometrium Progesterone Virtus Pharmaceuticals NDA Current 69543-372 Prometrium Progesterone Virtus Pharmaceuticals NDA Current 69543-372 Prometrium Progesterone Virtus Pharmaceuticals NDA Current 69543-372 Prometrium Progesterone Virtus Pharmaceuticals NDA Current 69543-373 Prometrium Progesterone Virtus Pharmaceuticals NDA Current 69543-373 Prometrium Progesterone Virtus Pharmaceuticals NDA Current 69543-373 Prometrium Progesterone Virtus Pharmaceuticals NDA Current 69543-373 Prometrium Progesterone Virtus Pharmaceuticals NDA Current 69543-374 Progesterone Progesterone Virtus Pharmaceuticals NDA Current 69543-374 Progesterone Progesterone Virtus Pharmaceuticals NDA Current 69543-374 Progesterone Progesterone Virtus Pharmaceuticals NDA Current 69543-375 Progesterone Progesterone Virtus Pharmaceuticals NDA Current 69543-375 Progesterone Progesterone Virtus Pharmaceuticals NDA Current 69543-375 Progesterone Progesterone Virtus Pharmaceuticals NDA Current 72989-372 Prometrium Progesterone Acertis Pharmaceuticals, LLC NDA Current 72989-373 Prometrium Progesterone Acertis Pharmaceuticals, LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 85032 SUPPL 2026-02-12 85013 SUPPL 2026-02-12 77562 SUPPL 2024-02-20 77536 SUPPL 2024-02-16 71518 SUPPL 2022-07-05 71513 SUPPL 2022-07-05 11715 SUPPL 2011-11-04 19215 SUPPL 2011-11-03 1615 SUPPL 2009-07-07 33950 SUPPL 2009-07-06 19214 SUPPL 2004-03-10 20350 ORIG 1998-05-14 11714 ORIG 1998-05-14 1614 ORIG 1998-05-14