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Generated: November 12, 2018

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Details for New Drug Application (NDA): 208470

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NDA 208470 describes INTRAROSA, which is a drug marketed by Amag Pharms Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the INTRAROSA profile page.

The generic ingredient in INTRAROSA is prasterone. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the prasterone profile page.
Summary for 208470
Tradename:INTRAROSA
Applicant:Amag Pharms Inc
Ingredient:prasterone
Patents:3
Generic Entry Opportunity Date for 208470
Generic Entry Date for 208470*:
Constraining patent/regulatory exclusivity:
Dosage:
INSERT;VAGINAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 208470
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INTRAROSA prasterone INSERT;VAGINAL 208470 NDA AMAG Pharmaceuticals, Inc. 64011-601 64011-601-14 1 BOX in 1 BOX (64011-601-14) > 14 BLISTER PACK in 1 BOX > 1 INSERT in 1 BLISTER PACK
INTRAROSA prasterone INSERT;VAGINAL 208470 NDA AMAG Pharmaceuticals, Inc. 64011-601 64011-601-28 1 BOX in 1 BOX (64011-601-28) > 28 BLISTER PACK in 1 BOX > 1 INSERT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INSERT;VAGINALStrength6.5MG
Approval Date:Nov 16, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 16, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Mar 19, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Aug 7, 2028Product Flag?YSubstance Flag?Delist Request?

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