Details for New Drug Application (NDA): 080983
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NDA 080983 describes SONAZINE, which is a drug marketed by Saptalis Pharms and Chartwell Rx and is included in two NDAs. It is available from one supplier. Additional details are available on the SONAZINE profile page.
The generic ingredient in SONAZINE is chlorpromazine hydrochloride. There are twenty-four drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the chlorpromazine hydrochloride profile page.
The generic ingredient in SONAZINE is chlorpromazine hydrochloride. There are twenty-four drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the chlorpromazine hydrochloride profile page.
Summary for 080983
| Tradename: | SONAZINE |
| Applicant: | Saptalis Pharms |
| Ingredient: | chlorpromazine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 080983
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SONAZINE | chlorpromazine hydrochloride | CONCENTRATE;ORAL | 080983 | ANDA | Saptalis Pharmaceuticals, LLC. | 71656-101 | 71656-101-08 | 240 mL in 1 BOTTLE, PLASTIC (71656-101-08) |
| SONAZINE | chlorpromazine hydrochloride | CONCENTRATE;ORAL | 080983 | ANDA | Saptalis Pharmaceuticals, LLC. | 71656-102 | 71656-102-04 | 120 mL in 1 BOTTLE, PLASTIC (71656-102-04) |
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CONCENTRATE;ORAL | Strength | 30MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 005
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CONCENTRATE;ORAL | Strength | 100MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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