Details for New Drug Application (NDA): 065173
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NDA 065173 describes PAROMOMYCIN SULFATE, which is a drug marketed by Heritage Pharms and Sun Pharm Inds Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the PAROMOMYCIN SULFATE profile page.
The generic ingredient in PAROMOMYCIN SULFATE is paromomycin sulfate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the paromomycin sulfate profile page.
The generic ingredient in PAROMOMYCIN SULFATE is paromomycin sulfate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the paromomycin sulfate profile page.
Summary for 065173
| Tradename: | PAROMOMYCIN SULFATE |
| Applicant: | Heritage Pharms |
| Ingredient: | paromomycin sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065173
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PAROMOMYCIN SULFATE | paromomycin sulfate | CAPSULE;ORAL | 065173 | ANDA | Waylis Therapeutics LLC | 80725-250 | 80725-250-01 | 100 CAPSULE in 1 BOTTLE (80725-250-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Dec 14, 2007 | TE: | RLD: | No | |||||
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