Home Applications 050756 Application 050756
Type NDA
Sponsor BAUSCH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BENZACLIN BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GEL;TOPICAL 5%;EQ 1% BASE Yes Yes 002 BENZACLIN BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GEL;TOPICAL 5%;EQ 1% 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050756-001 BENZACLIN BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL / TOPICAL RLD 2000-12-21 N050756-002 BENZACLIN BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL / TOPICAL 2007-04-20
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 3 of 3 · 88 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 2022-10-28 04:53 UTC 2022-10 N050756-001 BENZACLIN 5%;EQ 1% BASE GEL / TOPICAL AB RLD, RS 2000-12-21 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050756-002 BENZACLIN 5%;EQ 1% BASE GEL / TOPICAL 2007-04-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050756-001 BENZACLIN 5%;EQ 1% BASE GEL / TOPICAL AB RLD, RS 2000-12-21 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050756-002 BENZACLIN 5%;EQ 1% BASE GEL / TOPICAL 2007-04-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050756-001 BENZACLIN 5%;EQ 1% BASE GEL / TOPICAL AB RLD, RS 2000-12-21 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050756-002 BENZACLIN 5%;EQ 1% BASE GEL / TOPICAL 2007-04-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050756-001 BENZACLIN 5%;EQ 1% BASE GEL / TOPICAL RLD 2000-12-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050756-002 BENZACLIN 5%;EQ 1% BASE GEL / TOPICAL 2007-04-20 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0187-5190 Benzaclin Clindamycin phosphate and benzoyl peroxide Valeant Pharmaceuticals North America LLC NDA Current 0187-5190 Benzaclin Clindamycin phosphate and benzoyl peroxide Bausch Health US LLC NDA Current 0187-5190 Benzaclin Clindamycin phosphate and benzoyl peroxide Bausch Health US LLC NDA Current 0187-5190 Benzaclin Clindamycin phosphate and benzoyl peroxide Bausch Health Americas, Inc. NDA Current 68682-190 Clindamycin phosphate and benzoyl peroxide Clindamycin phosphate and benzoyl peroxide Oceanside Pharmaceuticals NDA Current 68682-190 Clindamycin phosphate and benzoyl peroxide Clindamycin phosphate and benzoyl peroxide Oceanside Pharmaceuticals NDA Current