Details for New Drug Application (NDA): 018615
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NDA 018615 describes SULFATRIM PEDIATRIC, which is a drug marketed by Pharm Assoc and is included in one NDA. It is available from three suppliers. Additional details are available on the SULFATRIM PEDIATRIC profile page.
The generic ingredient in SULFATRIM PEDIATRIC is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.
The generic ingredient in SULFATRIM PEDIATRIC is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.
Summary for 018615
| Tradename: | SULFATRIM PEDIATRIC |
| Applicant: | Pharm Assoc |
| Ingredient: | sulfamethoxazole; trimethoprim |
| Patents: | 0 |
Suppliers and Packaging for NDA: 018615
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SULFATRIM | sulfamethoxazole; trimethoprim | SUSPENSION;ORAL | 018615 | NDA | PAI Holdings, LLC dba PAI Pharma | 0121-0853 | 0121-0853-20 | 10 CUP, UNIT-DOSE in 1 TRAY (0121-0853-20) / 20 mL in 1 CUP, UNIT-DOSE |
| SULFATRIM | sulfamethoxazole; trimethoprim | SUSPENSION;ORAL | 018615 | NDA | PAI Holdings, LLC dba PAI Pharma | 0121-0854 | 0121-0854-16 | 473 mL in 1 BOTTLE (0121-0854-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 200MG/5ML;40MG/5ML | ||||
| Approval Date: | Jan 7, 1983 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION;ORAL | Strength | 200MG/5ML;40MG/5ML | ||||
| Approval Date: | Jan 7, 1983 | TE: | RLD: | No | |||||
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