Details for New Drug Application (NDA): 076395
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NDA 076395 describes DILTZAC, which is a drug marketed by Apotex and is included in one NDA. Additional details are available on the DILTZAC profile page.
The generic ingredient in DILTZAC is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
The generic ingredient in DILTZAC is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 076395
| Tradename: | DILTZAC |
| Applicant: | Apotex |
| Ingredient: | diltiazem hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
| Approval Date: | Feb 1, 2006 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 180MG | ||||
| Approval Date: | Feb 1, 2006 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 240MG | ||||
| Approval Date: | Feb 1, 2006 | TE: | RLD: | No | |||||
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