USFDA APPLICATION NUMBER - 20648 / DOSAGE - GEL;RECTAL - 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
DIAZEPAM(UNII: Q3JTX2Q7TU) (DIAZEPAM - UNII:Q3JTX2Q7TU) | DIAZEPAM | 20mg in 4 | 2.5mg in 0.5 | 10mg in 2 |
Inactive Ingredients
Ingredient Name | Bausch Health US, LLC | Oceanside Pharmaceuticals | Teva Pharmaceuticals USA, Inc. |
---|---|---|---|
ALCOHOL(3K9958V90M) | |||
BENZOIC ACID(8SKN0B0MIM) | |||
BENZYL ALCOHOL(LKG8494WBH) | |||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||
PROPYLENE GLYCOL(6DC9Q167V3) | |||
SODIUM BENZOATE(OJ245FE5EU) | |||
WATER(059QF0KO0R) |
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