Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020700
Company: MYLAN SPECIALITY LP

Products on NDA 020700

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MUSE	ALPROSTADIL	0.125MG	SUPPOSITORY;URETHRAL	Discontinued	None	Yes	No
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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020700

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.