Home Applications 214688 Application 214688
Type ANDA
Sponsor GLENMARK PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE AEROSOL, FOAM;TOPICAL 0.064%;0.005% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% AEROSOL, FOAM / TOPICAL 2023-03-21
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL 2023-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL 2023-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL 2023-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL 2023-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL 2023-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL 2023-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL 2023-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB 2023-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB 2023-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB 2023-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB 2023-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB 2023-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB 2023-03-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB 2023-03-21 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB 2023-03-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB 2023-03-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB 2023-03-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB 2023-03-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB 2023-03-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB 2023-03-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB 2023-03-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB 2023-03-21 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214688-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% AEROSOL, FOAM / TOPICAL 2023-03-21 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
Documents# Document, Submission type, Date table Document Submission type Date 74114 ORIG 2023-04-28