Home Applications 206575 Application 206575
Type ANDA
Sponsor TARO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GEL;TOPICAL 2.5%;EQ 1.2% BASE No No
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 A206575-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-08-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206575-001 AB
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 2 of 2 · 43 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 2022-09-29 23:25 UTC 2022-09 A206575-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-08-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206575-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-08-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206575-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 2.5%;EQ 1.2% BASE GEL / TOPICAL AB 2019-08-19 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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.
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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51672-1367 Clindamycin Phosphate and Benzoyl Peroxide Clindamycin Phosphate and Benzoyl Peroxide Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-1367 Clindamycin Phosphate and Benzoyl Peroxide Clindamycin Phosphate and Benzoyl Peroxide Taro Pharmaceuticals U.S.A., Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 54818 ORIG 2018-07-06