Details for New Drug Application (NDA): 077561
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NDA 077561 describes ZIPRASIDONE HYDROCHLORIDE, which is a drug marketed by Apotex, Aurobindo Pharma, Chartwell Rx, Dr Reddys Labs Inc, Lupin Pharms, Macleods Pharms Ltd, Mylan, Sandoz Inc, and Zydus Lifesciences, and is included in nine NDAs. It is available from twenty-one suppliers. Additional details are available on the ZIPRASIDONE HYDROCHLORIDE profile page.
The generic ingredient in ZIPRASIDONE HYDROCHLORIDE is ziprasidone hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-three 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 are twenty-three drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ziprasidone hydrochloride profile page.
Summary for 077561
| Tradename: | ZIPRASIDONE HYDROCHLORIDE |
| Applicant: | Apotex |
| Ingredient: | ziprasidone hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 077561
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZIPRASIDONE HYDROCHLORIDE | ziprasidone hydrochloride | CAPSULE;ORAL | 077561 | ANDA | AvPAK | 50268-811 | 50268-811-12 | 20 BLISTER PACK in 1 BOX (50268-811-12) / 1 CAPSULE in 1 BLISTER PACK (50268-811-11) |
| ZIPRASIDONE HYDROCHLORIDE | ziprasidone hydrochloride | CAPSULE;ORAL | 077561 | ANDA | AvPAK | 50268-812 | 50268-812-12 | 20 BLISTER PACK in 1 BOX (50268-812-12) / 1 CAPSULE in 1 BLISTER PACK (50268-812-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Mar 2, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Mar 2, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 60MG BASE | ||||
| Approval Date: | Mar 2, 2012 | TE: | AB | RLD: | No | ||||
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