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Details for New Drug Application (NDA): 091667

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NDA 091667 describes MISOPROSTOL, which is a drug marketed by Novel Labs Inc and Ivax Sub Teva Pharms and is included in two NDAs. It is available from thirteen suppliers. Additional details are available on the MISOPROSTOL profile page.

The generic ingredient in MISOPROSTOL is misoprostol. There are fourteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the misoprostol profile page.

Summary for NDA: 091667

Tradename:
MISOPROSTOL
Applicant:
Novel Labs Inc
Ingredient:
misoprostol
Patents:0
Therapeutic Class:Gastrointestinal Agents
Hormonal Agents, Stimulant/Replacement/Modifying (Prostaglandins)
Formulation / Manufacturing:see details

Pharmacology for NDA: 091667

Suppliers and Packaging for NDA: 091667

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MISOPROSTOL
misoprostol
TABLET;ORAL 091667 ANDA KAISER FOUNDATION HOSPITALS 0179-0218 0179-0218-98 2 TABLET in 1 CARTON (0179-0218-98)
MISOPROSTOL
misoprostol
TABLET;ORAL 091667 ANDA Aidarex Pharmaceuticals LLC 33261-076 33261-076-13 4 TABLET in 1 BOTTLE, PLASTIC (33261-076-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.1MG
Approval Date:Jul 25, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.2MG
Approval Date:Jul 25, 2012TE:ABRLD:No


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