Details for New Drug Application (NDA): 218587
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NDA 218587 describes DILTIAZEM HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Alembic, Apotex, Biovail, Chartwell Rx, Dr Reddys Labs Sa, Endo Operations, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Norvium Bioscience, Novast Labs, Sun Pharm, Teva, Twi Pharms, Utopic Pharms, Valeant Pharms North, Zydus Pharms, Dr Reddys, Eugia Pharma, Hikma, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Rising, Sagent, Amta, Sciegen Pharms Inc, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, Teva Pharms, and Exela Pharma, and is included in fifty-two NDAs. It is available from forty-nine suppliers. Additional details are available on the DILTIAZEM HYDROCHLORIDE profile page.
The generic ingredient in DILTIAZEM HYDROCHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
The generic ingredient in DILTIAZEM HYDROCHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 218587
| Tradename: | DILTIAZEM HYDROCHLORIDE |
| Applicant: | Alembic |
| Ingredient: | diltiazem hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 218587
| Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors |
Suppliers and Packaging for NDA: 218587
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 218587 | ANDA | Alembic Pharmaceuticals Limited | 46708-815 | 46708-815-31 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-815-31) |
| DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 218587 | ANDA | Alembic Pharmaceuticals Limited | 46708-815 | 46708-815-71 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-815-71) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
| Approval Date: | Oct 18, 2024 | TE: | AB2 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 180MG | ||||
| Approval Date: | Oct 18, 2024 | TE: | AB2 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 240MG | ||||
| Approval Date: | Oct 18, 2024 | TE: | AB2 | RLD: | No | ||||
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