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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210765
Company: TOLMAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% SUSPENSION;TOPICAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/11/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210765Orig1s000ltr.pdf

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE

SUSPENSION;TOPICAL; 0.064%;0.005%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% SUSPENSION;TOPICAL Prescription No AB 213269 TARO PHARMS
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% SUSPENSION;TOPICAL Prescription No AB 210765 TOLMAR
CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% SUSPENSION;TOPICAL Prescription No AB 212367 PADAGIS ISRAEL
TACLONEX BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% SUSPENSION;TOPICAL Prescription Yes AB 022185 LEO PHARMA AS
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