Zolpidem Tartrate - Zolpidem Tartrate
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Supplier starting with: P > PAR PHARMACEUTICAL, INC.
Field |
Value |
NDC Code: |
10370-116 |
Proprietary Name: |
Zolpidem Tartrate |
Suffix: |
Extended-Release |
Non-Proprietary Name: |
Zolpidem Tartrate |
Dosage Form: |
TABLET, FILM COATED, EXTENDED RELEASE |
Method: |
ORAL |
Original Marketing Date: |
06-12-2011 |
Category Name: |
ANDA |
Application Number: |
ANDA078148 |
Labeler: |
PAR PHARMACEUTICAL, INC. |
Substance Name: |
ZOLPIDEM TARTRATE |
Active Numerator Strength: |
12.5 |
Active Ingredient Unit: |
mg/1 |
Pharm Classes: |
gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] |
DEA Schedule: |
CIV |