Details for New Drug Application (NDA): 090348
NDA 090348 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 090348
| Tradename: | ZIPRASIDONE HYDROCHLORIDE |
| Applicant: | Chartwell Rx |
| Ingredient: | ziprasidone hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090348
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZIPRASIDONE HYDROCHLORIDE | ziprasidone hydrochloride | CAPSULE;ORAL | 090348 | ANDA | Chartwell RX, LLC | 62135-991 | 62135-991-60 | 60 CAPSULE in 1 BOTTLE (62135-991-60) |
| ZIPRASIDONE HYDROCHLORIDE | ziprasidone hydrochloride | CAPSULE;ORAL | 090348 | ANDA | Chartwell RX, LLC | 62135-992 | 62135-992-60 | 60 CAPSULE in 1 BOTTLE (62135-992-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Sep 5, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Sep 5, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 60MG BASE | ||||
| Approval Date: | Sep 5, 2012 | TE: | AB | RLD: | No | ||||
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