FDA.reportPublic FDA data

Application 203790

Type
ANDA
Sponsor
ACTAVIS MID ATLANTIC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADAPALENE AND BENZOYL PEROXIDEADAPALENE; BENZOYL PEROXIDEGEL;TOPICAL0.1%;2.5%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203790-001ADAPALENE AND BENZOYL PEROXIDEADAPALENE; BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-30

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-303f01610625f2…
2019-09-15 20:21 UTC2019-09A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICAL2015-09-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203790-001ADAPALENE AND BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALAB2015-09-30e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203790-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203790-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203790-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203790-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203790-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203790-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203790-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203790-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203790-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203790-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203790-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203790-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203790-001AB1ea99ee380514…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203790-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203790-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203790-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203790-001AB1cb3db0bc1861…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEGlenmark Pharmaceuticals Inc., USAfc8e868f-9699-4ae6-83d5-fa27789336cd2026-11-23Warnings, Adverse reactionsName fallback
brand name: adapalene and benzoyl peroxide
Adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEAurobindo Pharma Limited25e4ee12-f43a-4c87-9e34-64e91d06a3682026-07-23Warnings, Adverse reactionsName fallback
brand name: Adapalene and benzoyl peroxide
ADAPALENE and BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.a53f1aa5-d3d1-45af-8728-8f36090f49da2025-07-03Warnings, Adverse reactionsName fallback
brand name: ADAPALENE and BENZOYL PEROXIDE
Adapalene and Benzoyl PeroxideADAPALENE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.13fc72e9-7178-4a8b-9fe8-d88ba591dac82025-07-02Warnings, Adverse reactionsName fallback
brand name: Adapalene and Benzoyl Peroxide
Adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEZydus Lifesciences Limitedd374a9b9-3ee9-4bc4-bcb9-a947d76cb6e52025-06-13Name fallback
brand name: Adapalene and benzoyl peroxide
Adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEViona Pharmaceuticals Inc3a0fa489-4720-4760-a476-2317aef5a2312025-06-13Warnings, Adverse reactionsName fallback
brand name: Adapalene and benzoyl peroxide
ADAPALENE AND BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDE TOPICALAlembic Pharmaceuticals Limited2d4e5111-4f9f-42dd-8cf7-56bdc51fbbad2025-05-27Warnings, Adverse reactionsName fallback
brand name: ADAPALENE AND BENZOYL PEROXIDE
ADAPALENE AND BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDE TOPICALAlembic Pharmaceuticals Inc.73a32997-23da-46b6-8652-7197f55c98472025-05-21Warnings, Adverse reactionsName fallback
brand name: ADAPALENE AND BENZOYL PEROXIDE
adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEBryant Ranch Prepackc2b4c7a4-05e5-4e94-9f09-7f8f68f99eab2024-11-07Warnings, Adverse reactionsName fallback
brand name: adapalene and benzoyl peroxide
adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEBryant Ranch Prepack36b05829-02b2-48a1-a5ae-e8a3066603f52024-10-18Warnings, Adverse reactionsName fallback
brand name: adapalene and benzoyl peroxide
ADAPALENE AND BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDEBryant Ranch Prepackceae42d9-0264-4a52-a17a-af68b2538ff92024-03-13Warnings, Adverse reactionsName fallback
brand name: ADAPALENE AND BENZOYL PEROXIDE
ADAPALENE AND BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDEBryant Ranch Prepack91161d2f-8990-4268-bd74-f60cf33aa2a12024-01-15Warnings, Adverse reactionsName fallback
brand name: ADAPALENE AND BENZOYL PEROXIDE
adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltde50e3ef9-3a9b-4172-a908-71c973a7fb5c2023-02-01Warnings, Adverse reactionsName fallback
brand name: adapalene and benzoyl peroxide
adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEMayne Pharma Inc.56541736-c70e-4fcd-9614-6cfdc50441362022-08-31Warnings, Adverse reactionsName fallback
brand name: adapalene and benzoyl peroxide
ADAPALENE AND BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd92dcba02-f42f-482d-8cd5-2b5ab8fa540a2022-06-02Warnings, Adverse reactionsName fallback
brand name: ADAPALENE AND BENZOYL PEROXIDE
Adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDETeva Pharmaceuticals, Inc.05babd5f-18ab-4646-8962-cb000ed0f9a82022-05-01Warnings, Adverse reactionsName fallback
brand name: Adapalene and benzoyl peroxide

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0472-0310Adapalene and Benzoyl PeroxideAdapalene and Benzoyl PeroxideActavis Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10249ORIG2015-10-02
10250ORIG2015-04-13