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Details for New Drug Application (NDA): 205231
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NDA 205231 describes DILTIAZEM HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Biovail, Mylan, Nesher Pharms, Novast Labs, Par Pharm, Sandoz, Sun Pharm, Teva, Twi Pharms, Valeant Pharms North, Zydus Pharms, Akorn Inc, Athenex Inc, Dr Reddys, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, West-ward Pharms Int, Apothecon, Chartwell Molecules, Ivax Sub Teva Pharms, and Teva Pharms, and is included in thirty-nine NDAs. It is available from thirty-seven 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. Forty-three 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. Forty-three suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 205231
| Tradename: | DILTIAZEM HYDROCHLORIDE |
| Applicant: | Twi Pharms |
| Ingredient: | diltiazem hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205231
| Mechanism of Action | Calcium Channel Antagonists |
Suppliers and Packaging for NDA: 205231
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205231 | ANDA | TWi Pharmaceuticals, Inc. | 24979-026 | 24979-026-02 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-02) |
| DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205231 | ANDA | TWi Pharmaceuticals, Inc. | 24979-026 | 24979-026-06 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
| Approval Date: | Aug 30, 2018 | TE: | AB3 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 180MG | ||||
| Approval Date: | Aug 30, 2018 | TE: | AB3 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 240MG | ||||
| Approval Date: | Aug 30, 2018 | TE: | AB3 | RLD: | No | ||||
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