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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): 075373

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 OINTMENT, 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
06/22/1999 ORIG-1 Approval

Letter (PDF)

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75373ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-373_Betamethasone%20Dipropionate.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/09/2020 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

06/09/2020 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

05/12/2016 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/12/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

BETAMETHASONE DIPROPIONATE

OINTMENT, 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 OINTMENT, AUGMENTED;TOPICAL Prescription No AB 074304 ACTAVIS MID ATLANTIC
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE OINTMENT, AUGMENTED;TOPICAL Prescription No AB 075373 FOUGERA PHARMS
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE OINTMENT, AUGMENTED;TOPICAL Prescription No AB 209106 LUPIN LTD
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE OINTMENT, AUGMENTED;TOPICAL Prescription No AB 076753 TARO
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE OINTMENT, AUGMENTED;TOPICAL Prescription No AB 206118 TELIGENT
DIPROLENE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE OINTMENT, AUGMENTED;TOPICAL Prescription Yes AB 018741 MERCK SHARP DOHME
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