Home Applications 201615 Application 201615
Type ANDA
Sponsor TOLMAR Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE OINTMENT;TOPICAL 0.064%;0.005% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A201615-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% OINTMENT / TOPICAL 2013-01-14
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 A201615-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2013-01-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201615-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2013-01-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201615-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL 2013-01-14 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 7 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Calcipotriene and Betamethasone Dipropionate CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE Sun Pharmaceutical Industries, Inc. 1d0ab2e6-1ab1-4d3e-ad55-7fa26446f191 2025-07-01 Warnings, Adverse reactions Name fallback brand name: Calcipotriene and Betamethasone Dipropionate calcipotriene and betamethasone dipropionate CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE Cosette Pharmaceuticals, Inc. 1eba330b-ce18-6b12-e063-6294a90a8763 2024-08-13 Warnings, Adverse reactions Name fallback brand name: calcipotriene and betamethasone dipropionate Calcipotriene and Betamethasone Dipropionate CALCIPOTRIENE, BETAMETHASONE DIPROPIONATE Padagis Israel Pharmaceuticals Ltd ba55ff2b-9cfe-40dc-9dac-718cf141c171 2024-04-30 Warnings, Adverse reactions Name fallback brand name: Calcipotriene and Betamethasone Dipropionate Calcipotriene and Betamethasone Dipropionate CALCIPOTRIENE, BETAMETHASONE DIPROPIONATE Bryant Ranch Prepack d223e857-590e-48b9-b33e-1275537a508e 2024-02-08 Warnings, Adverse reactions Name fallback brand name: Calcipotriene and Betamethasone Dipropionate Calcipotriene and Betamethasone Dipropionate CALCIPOTRIENE, BETAMETHASONE DIPROPIONATE Bryant Ranch Prepack 174c5378-f2b9-4e9e-931a-4123137be62d 2023-12-07 Warnings, Adverse reactions Name fallback brand name: Calcipotriene and Betamethasone Dipropionate Calcipotriene and Betamethasone Dipropionate CALCIPOTRIENE, BETAMETHASONE DIPROPIONATE Bryant Ranch Prepack d4b301c5-704a-406d-9d9c-74f006334f8a 2023-07-17 Warnings, Adverse reactions Name fallback brand name: Calcipotriene and Betamethasone Dipropionate Calcipotriene and Betamethasone Dipropionate CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE Prasco Laboratories d9493e66-251c-426c-90a8-1bf1e526ab85 2022-12-12 Warnings, Adverse reactions Name fallback brand name: Calcipotriene and Betamethasone Dipropionate
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 0781-7165 CALCIPOTRIENE 0.005% AND BETAMETHASONE DIPROPIONATE 0.064% calcipotriene 0.005% and betamethasone dipropionate 0.064% Sandoz Inc. ANDA Current 0781-7165 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE calcipotriene and betamethasone dipropionate Sandoz Inc. ANDA Current 0781-7165 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE calcipotriene and betamethasone dipropionate Sandoz Inc. ANDA Current 0781-7165 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE calcipotriene and betamethasone dipropionate Sandoz Inc. ANDA Current 0781-7165 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE calcipotriene and betamethasone dipropionate Sandoz Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 32122 ORIG 2013-01-17