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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 090633


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NDA 090633 describes CALCIPOTRIENE, which is a drug marketed by Chartwell Rx, Glenmark Speclt, Glenmark Pharms Inc, Cosette, Fougera Pharms, Hikma, Glenmark Pharms Ltd, Padagis Israel, and Taro, and is included in fourteen NDAs. It is available from six suppliers. Additional details are available on the CALCIPOTRIENE profile page.

The generic ingredient in CALCIPOTRIENE is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
Summary for 090633
Tradename:CALCIPOTRIENE
Applicant:Glenmark Pharms Inc
Ingredient:calcipotriene
Patents:0
Pharmacology for NDA: 090633
Suppliers and Packaging for NDA: 090633
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCIPOTRIENE calcipotriene OINTMENT;TOPICAL 090633 ANDA Golden State Medical Supply, Inc. 51407-606 51407-606-12 1 TUBE in 1 CARTON (51407-606-12) / 120 g in 1 TUBE
CALCIPOTRIENE calcipotriene OINTMENT;TOPICAL 090633 ANDA Golden State Medical Supply, Inc. 51407-606 51407-606-60 60 g in 1 TUBE (51407-606-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.005%
Approval Date:Mar 24, 2010TE:ABRLD:No

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