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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 twelve 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

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
TABLET;ORAL 091667 ANDA KAISER FOUNDATION HOSPITALS 0179-0218 0179-0218-98 2 TABLET in 1 CARTON (0179-0218-98)
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.