Details for New Drug Application (NDA): 091022
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The generic ingredient in DILTIAZEM HYDROCHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 091022
Tradename: | DILTIAZEM HYDROCHLORIDE |
Applicant: | Sandoz |
Ingredient: | diltiazem hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
Approval Date: | Sep 28, 2012 | TE: | AB4 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 180MG | ||||
Approval Date: | Sep 28, 2012 | TE: | AB4 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 240MG | ||||
Approval Date: | Sep 28, 2012 | TE: | AB4 | RLD: | No |
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