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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072538
Company: PADAGIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE LOTION;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
01/31/1990 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/28/2013 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
12/16/1997 SUPPL-5 Labeling

Label is not available on this site.
01/24/1997 SUPPL-4 Labeling

Label is not available on this site.
05/05/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

BETAMETHASONE DIPROPIONATE

LOTION;TOPICAL; EQ 0.05% BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE LOTION;TOPICAL Prescription No AB 071467 COSETTE
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE LOTION;TOPICAL Prescription No AB 070275 FOUGERA PHARMS INC
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE LOTION;TOPICAL Prescription No AB 072538 PADAGIS US
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