Details for New Drug Application (NDA): 204375
✉ Email this page to a colleague
NDA 204375 describes ZIPRASIDONE HYDROCHLORIDE, which is a drug marketed by Apotex, Aurobindo Pharma, Chartwell Rx, Dr Reddys Labs Inc, Lupin Pharms, Macleods Pharms, Mylan, Sandoz Inc, and Zydus Lifesciences, and is included in nine NDAs. It is available from sixteen suppliers. Additional details are available on the ZIPRASIDONE HYDROCHLORIDE profile page.
The generic ingredient in ZIPRASIDONE HYDROCHLORIDE is ziprasidone hydrochloride. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ziprasidone hydrochloride profile page.
The generic ingredient in ZIPRASIDONE HYDROCHLORIDE is ziprasidone hydrochloride. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ziprasidone hydrochloride profile page.
Summary for 204375
| Tradename: | ZIPRASIDONE HYDROCHLORIDE |
| Applicant: | Macleods Pharms |
| Ingredient: | ziprasidone hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204375
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZIPRASIDONE HYDROCHLORIDE | ziprasidone hydrochloride | CAPSULE;ORAL | 204375 | ANDA | Macleods Pharmaceuticals Limited | 33342-144 | 33342-144-09 | 60 CAPSULE in 1 BOTTLE (33342-144-09) |
| ZIPRASIDONE HYDROCHLORIDE | ziprasidone hydrochloride | CAPSULE;ORAL | 204375 | ANDA | Macleods Pharmaceuticals Limited | 33342-144 | 33342-144-12 | 10 BLISTER PACK in 1 CARTON (33342-144-12) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Feb 17, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Feb 17, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 60MG BASE | ||||
| Approval Date: | Feb 17, 2017 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
