Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070275
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 LOTION;TOPICAL Prescription AB No 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
08/12/1985 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
08/17/1995 SUPPL-10 Labeling

Label is not available on this site.

01/06/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/03/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/03/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/03/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/29/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/21/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/28/1986 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

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 209896 AKORN
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 PERRIGO NEW YORK

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