Home Applications 050805 Application 050805
Type NDA
Sponsor GALDERMA LABS LP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ORACEA DOXYCYCLINE CAPSULE;ORAL 40MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N050805-001 ORACEA DOXYCYCLINE 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050805-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N050805-001 7749532 2027-12-19 U-1063 Drug product
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 · 44 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 2026-10-15 13:18:30 2026-09 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 3a93d1ddd44b…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 2 of 8 · 313 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2024-10-29 15:01 UTC 2024-10 N050805-001 8206740 2025-12-24 U-925 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050805-001 7749532 2027-12-19 U-1063 Drug product d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050805-001 8394405 2024-04-07 U-925 Drug product 2013-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050805-001 8394406 2024-04-07 U-925 Drug product 2013-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050805-001 8470364 2024-04-07 U-925 Drug product 2013-06-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050805-001 8709478 2024-04-07 U-1063 2014-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050805-001 8206740 2025-12-24 U-925 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050805-001 7749532 2027-12-19 U-1063 Drug product 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050805-001 8394405 2024-04-07 U-925 Drug product 2013-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050805-001 8394406 2024-04-07 U-925 Drug product 2013-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050805-001 8470364 2024-04-07 U-925 Drug product 2013-06-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050805-001 8709478 2024-04-07 U-1063 2014-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050805-001 8206740 2025-12-24 U-925 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050805-001 7749532 2027-12-19 U-1063 Drug product 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050805-001 8394405 2024-04-07 U-925 Drug product 2013-03-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050805-001 8394406 2024-04-07 U-925 Drug product 2013-03-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050805-001 8470364 2024-04-07 U-925 Drug product 2013-06-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050805-001 8709478 2024-04-07 U-1063 2014-04-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050805-001 8206740 2025-12-24 U-925 Drug product 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050805-001 7749532 2027-12-19 U-1063 Drug product 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050805-001 8394405 2024-04-07 U-925 Drug product 2013-03-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050805-001 8394406 2024-04-07 U-925 Drug product 2013-03-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050805-001 8470364 2024-04-07 U-925 Drug product 2013-06-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050805-001 8709478 2024-04-07 U-1063 2014-04-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050805-001 8206740 2025-12-24 U-925 Drug product 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050805-001 7749532 2027-12-19 U-1063 Drug product 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050805-001 10058564 2022-04-05 U-1063 2018-09-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050805-001 7211267 2022-04-05 U-925 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050805-001 7232572 2022-04-05 U-925 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050805-001 8603506 2022-04-05 U-1063 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050805-001 9241946 2022-04-05 U-1063 2016-02-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050805-001 8394405 2024-04-07 U-925 Drug product 2013-03-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050805-001 8394406 2024-04-07 U-925 Drug product 2013-03-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050805-001 8470364 2024-04-07 U-925 Drug product 2013-06-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050805-001 8709478 2024-04-07 U-1063 2014-04-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050805-001 8206740 2025-12-24 U-925 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050805-001 7749532 2027-12-19 U-1063 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050805-001 10058564 2022-04-05 U-1063 2018-09-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050805-001 7211267 2022-04-05 U-925 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050805-001 7232572 2022-04-05 U-925 5d02ea3f76ae…
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 · 2 matching rows.
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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0299-3822 ORACEA DOXYCYCLINE Galderma Laboratories, L.P. NDA Current 0299-3822 ORACEA DOXYCYCLINE Galderma Laboratories, L.P. NDA Current 0299-3822 ORACEA DOXYCYCLINE Galderma Laboratories, L.P. NDA Current 0299-3822 ORACEA DOXYCYCLINE Galderma Laboratories, L.P. NDA Current 66993-815 DOXYCYCLINE DOXYCYCLINE Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-815 DOXYCYCLINE DOXYCYCLINE Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-815 DOXYCYCLINE DOXYCYCLINE Prasco Laboratories NDA AUTHORIZED GENERIC Current 69007-822 DOXYCYCLINE DOXYCYCLINE Owen Laboratories, Inc. NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 82356 SUPPL 2025-05-30 81873 SUPPL 2025-04-08 69702 SUPPL 2021-12-21 69617 SUPPL 2021-12-17 39372 SUPPL 2013-07-30 8327 SUPPL 2013-07-29 39371 SUPPL 2012-11-08 8326 SUPPL 2012-11-08 39370 SUPPL 2010-05-17 30593 SUPPL 2010-05-17 42749 ORIG 2008-02-22 39369 ORIG 2006-05-30 8325 ORIG 2006-05-30