Application 207917

Type
NDA
Sponsor
GALDERMA LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPIDUO FORTEADAPALENE; BENZOYL PEROXIDEGEL;TOPICAL0.3%;2.5%YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N207917-001EPIDUO FORTEADAPALENE; BENZOYL PEROXIDE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N207917-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALRLD, RS2015-07-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-153f01610625f2…
2019-09-15 20:21 UTC2019-09N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15b00525d2431f…
2019-07-19 19:46 UTC2019-07N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-153f0d92c62455…
2023-05-13 08:27 UTC2023-05N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15053a50430f4f…
2023-01-26 05:58 UTC2023-01N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N207917-001EPIDUO FORTE0.3%;2.5%GEL / TOPICALABRLD, RS2015-07-15cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N207917-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207917-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N207917-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207917-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207917-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207917-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207917-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207917-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207917-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207917-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207917-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207917-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207917-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207917-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207917-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207917-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207917-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207917-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N207917-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N207917-001AB1782e0a99824c…
2021-03-12 10:30 UTC2021-03N207917-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N207917-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N207917-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N207917-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N207917-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N207917-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N207917-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N207917-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N207917-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N207917-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N207917-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N207917-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N207917-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N207917-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N207917-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N207917-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N207917-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N207917-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N207917-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N207917-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 5 · 186 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207917-00184455432022-12-23U-10782015-07-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207917-00187854202022-12-23U-10782015-07-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207917-00188093052022-12-23U-10782016-01-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207917-00189368002022-12-23U-1078Drug product2015-07-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207917-00198146902022-12-23U-1078Drug product2017-12-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207917-00187038202023-03-12U-10782015-07-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207917-00187291272023-03-12U-10782015-07-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207917-00193811792023-03-12U-10782016-08-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207917-00193871872023-03-12U-10782016-08-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207917-00184455432022-12-23U-10782015-07-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207917-00187854202022-12-23U-10782015-07-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207917-00188093052022-12-23U-10782016-01-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207917-00189368002022-12-23U-1078Drug product2015-07-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207917-00198146902022-12-23U-1078Drug product2017-12-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207917-00187038202023-03-12U-10782015-07-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207917-00187291272023-03-12U-10782015-07-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207917-00193811792023-03-12U-10782016-08-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207917-00193871872023-03-12U-10782016-08-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207917-00184455432022-12-23U-10782015-07-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207917-00187854202022-12-23U-10782015-07-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207917-00188093052022-12-23U-10782016-01-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207917-00189368002022-12-23U-1078Drug product2015-07-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207917-00198146902022-12-23U-1078Drug product2017-12-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207917-00187038202023-03-12U-10782015-07-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207917-00187291272023-03-12U-10782015-07-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207917-00193811792023-03-12U-10782016-08-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207917-00193871872023-03-12U-10782016-08-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207917-00184455432022-12-23U-10782015-07-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207917-00187854202022-12-23U-10782015-07-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207917-00188093052022-12-23U-10782016-01-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207917-00189368002022-12-23U-1078Drug product2015-07-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207917-00198146902022-12-23U-1078Drug product2017-12-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207917-00187038202023-03-12U-10782015-07-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207917-00187291272023-03-12U-10782015-07-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207917-00193811792023-03-12U-10782016-08-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207917-00193871872023-03-12U-10782016-08-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N207917-00184455432022-12-23U-10782015-07-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N207917-00187854202022-12-23U-10782015-07-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N207917-00188093052022-12-23U-10782016-01-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N207917-00189368002022-12-23U-1078Drug product2015-07-24bb7c543d1eb4…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
epiduo forteADAPALENE AND BENZOYL PEROXIDEGalderma Laboratories, L.P.f4e5d381-098a-4c93-9ff0-002cae46daac2024-10-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 207917
application number: NDA207917
ndc (product): 0299-5906
adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEMayne Pharma Inc.56541736-c70e-4fcd-9614-6cfdc50441362022-08-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 207917
application number: NDA207917
ndc (product): 68308-662

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-6303adapalene and benzoyl peroxideadapalene and benzoyl peroxideTEVA PHARMACEUTICALS USA, INCNDA AUTHORIZED GENERICCurrent
0093-6303adapalene and benzoyl peroxideadapalene and benzoyl peroxideTEVA PHARMACEUTICALS USA, INCNDA AUTHORIZED GENERICCurrent
0299-5906epiduo forteadapalene and benzoyl peroxideGalderma Laboratories, L.P.NDACurrent
0299-5906epiduo forteadapalene and benzoyl peroxideGalderma Laboratories, L.P.NDACurrent
0299-5906epiduo forteadapalene and benzoyl peroxideGalderma Laboratories, L.P.NDACurrent
0299-5906epiduo forteadapalene and benzoyl peroxideGalderma Laboratories, L.P.NDACurrent
68308-662adapalene and benzoyl peroxideadapalene and benzoyl peroxideMayne Pharma Inc.NDA AUTHORIZED GENERICCurrent
68308-662adapalene and benzoyl peroxideadapalene and benzoyl peroxideMayne Pharma Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70859SUPPL2022-04-29
70858SUPPL2022-04-29
70845SUPPL2022-04-28
70844SUPPL2022-04-28
51451ORIG2018-01-01
43536ORIG2016-05-25
10625ORIG2015-07-20
40594ORIG2015-07-16
51449ORIG1900-01-01
51443ORIG1900-01-01