Home Applications 050803 Application 050803
Type NDA
Sponsor ALMIRALL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VELTIN CLINDAMYCIN PHOSPHATE; TRETINOIN GEL;TOPICAL 1.2%;0.025% Yes Yes
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 N050803-001 VELTIN CLINDAMYCIN PHOSPHATE; TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 RLD, RS 2010-07-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050803-001 AB2
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 · 44 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 N050803-001 VELTIN 1.2%;0.025% GEL / TOPICAL AB2 RLD, RS 2010-07-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050803-001 VELTIN 1.2%;0.025% GEL / TOPICAL AB2 RLD, RS 2010-07-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050803-001 VELTIN 1.2%;0.025% GEL / TOPICAL AB2 RLD, RS 2010-07-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050803-001 VELTIN 1.2%;0.025% GEL / TOPICAL AB2 RLD, RS 2010-07-16 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16110-071 VELTIN clindamycin phosphate and tretinoin Almirall, LLC NDA Current 16110-071 VELTIN clindamycin phosphate and tretinoin Aqua Pharmaceuticals NDA Current 16110-071 VELTIN clindamycin phosphate and tretinoin Almirall, LLC NDA Current 66993-959 Clindamycin Phosphate and Tretinion clindamycin phosphate and tretinoin Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-959 Clindamycin Phosphate and Tretinion clindamycin phosphate and tretinoin Prasco Laboratories NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 44787 ORIG 2011-01-28 42747 ORIG 2011-01-28 39367 ORIG 2010-07-22 8322 ORIG 2010-07-20