Home Applications 200456 Application 200456
Type ANDA
Sponsor SOFGEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROGESTERONE PROGESTERONE CAPSULE;ORAL 100MG No No 002 PROGESTERONE PROGESTERONE CAPSULE;ORAL 200MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200456-001 PROGESTERONE PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 A200456-002 PROGESTERONE PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28
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 3 · 82 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 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL BX 2012-09-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL BX 2012-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL BX 2012-09-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL BX 2012-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL BX 2012-09-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL BX 2012-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL BX 2012-09-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL BX 2012-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL BX 2012-09-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL BX 2012-09-28 782e0a99824c…
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 17478-766 Progesterone Progesterone Akorn, Inc. ANDA Current 17478-766 Progesterone Progesterone Akorn, Inc. ANDA Current 17478-766 Progesterone Progesterone Akorn ANDA Current 17478-767 Progesterone Progesterone Akorn, Inc. ANDA Current 17478-767 Progesterone Progesterone Akorn, Inc. ANDA Current 17478-767 Progesterone Progesterone Akorn ANDA Current 50090-2527 Progesterone Progesterone A-S Medication Solutions ANDA Current 50090-2527 Progesterone Progesterone A-S Medication Solutions ANDA Current 53002-1760 Progesterone Progesterone RPK Pharmaceuticals, Inc. ANDA Current 68788-7199 Progesterone Progesterone Preferred Pharmaceuticals Inc. ANDA Current 68788-7199 Progesterone Progesterone Preferred Pharmaceuticals Inc. ANDA Current 68788-7199 Progesterone Progesterone Preferred Pharmaceuticals Inc. ANDA Current 71205-293 Progesterone Progesterone Proficient Rx LP ANDA Current 71205-293 Progesterone Progesterone Proficient Rx LP ANDA Current 71205-293 Progesterone Progesterone Proficient Rx LP ANDA Current 71335-0825 Progesterone Progesterone Bryant Ranch Prepack ANDA Current 71335-0825 Progesterone Progesterone Bryant Ranch Prepack ANDA Current 71335-0825 Progesterone Progesterone Bryant Ranch Prepack ANDA Current 71335-0825 Progesterone Progesterone Bryant Ranch Prepack ANDA Current 71335-0835 Progesterone Progesterone Bryant Ranch Prepack ANDA Current 71335-0835 Progesterone Progesterone Bryant Ranch Prepack ANDA Current 71335-0835 Progesterone Progesterone Bryant Ranch Prepack ANDA Current 76420-070 Progesterone Progesterone Asclemed USA, Inc. ANDA Current 76420-071 Progesterone Progesterone Asclemed USA, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9826 ORIG 2012-10-02