Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021997

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EDLUAR (ZOLPIDEM TARTRATE)
5MG
Marketing Status: Prescription

Active Ingredient: ZOLPIDEM TARTRATE
Proprietary Name: EDLUAR
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021997
Product Number: 001
Approval Date: Mar 13, 2009
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Prescription
Patent and Exclusivity Information

EDLUAR (ZOLPIDEM TARTRATE)
10MG
Marketing Status: Prescription

Active Ingredient: ZOLPIDEM TARTRATE
Proprietary Name: EDLUAR
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021997
Product Number: 002
Approval Date: Mar 13, 2009
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Prescription
Patent and Exclusivity Information