Details for New Drug Application (NDA): 206997
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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-three suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 206997
Tradename: | DILTIAZEM HYDROCHLORIDE |
Applicant: | Accord Hlthcare |
Ingredient: | diltiazem hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 206997
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors |
Suppliers and Packaging for NDA: 206997
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206997 | ANDA | Accord Healthcare, Inc. | 16729-303 | 16729-303-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-303-01) |
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206997 | ANDA | Accord Healthcare, Inc. | 16729-303 | 16729-303-16 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-303-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
Approval Date: | Apr 28, 2020 | TE: | AB2 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 180MG | ||||
Approval Date: | Apr 28, 2020 | TE: | AB2 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 240MG | ||||
Approval Date: | Apr 28, 2020 | TE: | AB2 | RLD: | No |
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