Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020700
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MUSE ALPROSTADIL 0.125MG SUPPOSITORY;URETHRAL Prescription None Yes Yes
MUSE ALPROSTADIL 0.25MG SUPPOSITORY;URETHRAL Prescription None Yes Yes
MUSE ALPROSTADIL 0.5MG SUPPOSITORY;URETHRAL Prescription None Yes Yes
MUSE ALPROSTADIL 1MG SUPPOSITORY;URETHRAL Prescription None 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
11/19/1996 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/30/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/24/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/31/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/30/1998 SUPPL-7 Labeling

Label is not available on this site.

09/09/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/09/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/09/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/27/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/13/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/13/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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