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DIASTAT ACUDIAL (nda020648)- (10MG/2ML (5MG/ML),20MG/4ML (5MG/ML))

DIAZEPAM BAUSCH
10MG/2ML (5MG/ML),20MG/4ML (5MG/ML)
Yes Yes
2013-Sep-17 Expired
None None
None No
Diazepam rectal gel is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 years of age and older.
1 0 1
Total Other Developers 5
Drugs with Suitability No
10MG/2ML (5MG/ML) ** ** - - 1
20MG/4ML (5MG/ML) ** ** - - 1
NDA Sales Available Total Generic Sales Available
Yes 1
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
****** ***** **** *** ***** ************, ***. *********** *** ****** *****, ********, *** ****** (**) *****, ****** ****** (***) ***

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Expired
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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