Home Applications 020701 Application 020701
Type NDA
Sponsor ALLERGAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CRINONE PROGESTERONE GEL;VAGINAL 4% Yes Yes 002 CRINONE PROGESTERONE GEL;VAGINAL 8% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N020701-001 CRINONE PROGESTERONE 4% GEL / VAGINAL RLD 1997-07-31 N020701-002 CRINONE PROGESTERONE 8% GEL / VAGINAL RLD, RS 1997-07-31
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 · 84 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 2026-08-18 06:07:40 2026-07 N020701-001 CRINONE 4% GEL / VAGINAL RLD 1997-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 bb7c543d1eb4…
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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0023-6150 Crinone progesterone Allergan, Inc. NDA Current 0023-6151 Crinone progesterone Allergan, Inc. NDA Current 52544-255 Crinone progesterone Actavis Pharma, Inc. NDA Current 52544-256 Crinone progesterone Actavis Pharma, Inc. NDA Current 55056-0406 Prochieve progesterone Columbia Laboratories NDA Current 55056-0806 Crinone progesterone Columbia Laboratories, Inc. NDA Current 55056-0808 Crinone progesterone Columbia Laboratories, Inc. NDA Current 55056-0818 Crinone progesterone Columbia Laboratories, Inc. NDA Current 55056-1601 Prochieve progesterone Columbia Laboratories NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 13242 SUPPL 2013-08-22 35168 SUPPL 2011-12-14 35167 SUPPL 2011-12-14 25564 SUPPL 2011-12-14 13241 SUPPL 2011-12-14 3123 SUPPL 2011-12-14 3122 SUPPL 2011-12-14 41580 SUPPL 2007-11-19 13240 SUPPL 2005-03-29 3121 SUPPL 2005-03-29 25563 SUPPL 2003-11-26 3120 SUPPL 2003-09-29 41579 ORIG 2003-08-08 3119 SUPPL 2001-04-23 25562 SUPPL 2001-04-11