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BETAMETHASONE DIPROPIONATE از شرکت FOUGERA PHARMS

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BETAMETHASONE DIPROPIONATE از شرکت FOUGERA PHARMS

Abbreviated New Drug Application (ANDA): 077111

Company: FOUGERA PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE LOTION, AUGMENTED;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
05/21/2007 ORIG-1 Approval

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077111s000ltr.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/15/2020 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

06/15/2020 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

02/29/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

BETAMETHASONE DIPROPIONATE

LOTION, AUGMENTED;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, AUGMENTED;TOPICAL Prescription No AB 208849 AKORN
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE LOTION, AUGMENTED;TOPICAL Prescription No AB 077111 FOUGERA PHARMS
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE LOTION, AUGMENTED;TOPICAL Prescription No AB 077477 TARO
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE LOTION, AUGMENTED;TOPICAL Prescription No AB 206389 TELIGENT
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