Details for New Drug Application (NDA): 074910
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The generic ingredient in DILTIAZEM HYDROCHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 074910
Tradename: | DILTIAZEM HYDROCHLORIDE |
Applicant: | Mylan |
Ingredient: | diltiazem hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074910
Mechanism of Action | Calcium Channel Antagonists |
Suppliers and Packaging for NDA: 074910
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 074910 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6060 | 0378-6060-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6060-01) |
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 074910 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6090 | 0378-6090-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6090-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
Approval Date: | May 2, 1997 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 90MG | ||||
Approval Date: | May 2, 1997 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
Approval Date: | May 2, 1997 | TE: | AB1 | RLD: | No |
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