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BETAMETHASONE DIPROPIONATE از شرکت FOUGERA PHARMS INC

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BETAMETHASONE DIPROPIONATE از شرکت FOUGERA PHARMS INC

New Drug Application (NDA): 019141

Company: FOUGERA PHARMS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE OINTMENT;TOPICAL Prescription

AB

Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/04/1984 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
03/07/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/17/1995 SUPPL-13 Labeling

Label is not available on this site.

06/07/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/16/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/01/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/01/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/01/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/23/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/06/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/20/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/27/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/28/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

BETAMETHASONE DIPROPIONATE

OINTMENT;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 OINTMENT;TOPICAL Prescription No AB 071012 ACTAVIS MID ATLANTIC
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE OINTMENT;TOPICAL Prescription No AB 214048 CADILA
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE OINTMENT;TOPICAL Prescription Yes AB 019141 FOUGERA PHARMS INC
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE OINTMENT;TOPICAL Prescription No AB 074271 TARO
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