FDA.reportPublic FDA data

Application 208757

Type
ANDA
Sponsor
ACTAVIS LABS UT INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATEBENZOYL PEROXIDE;CLINDAMYCIN PHOSPHATEUNKNOWNUNKNOWNNoNo

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
A208757-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE3.75%;EQ 1.2% BASEGEL / TOPICALAB2026-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208757-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208757-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE3.75%;EQ 1.2% BASEGEL / TOPICALAB2026-08-07caaa826d4ba7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208757-001AB1caaa826d4ba7…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55247ORIG2018-08-20