Details for New Drug Application (NDA): 050567
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NDA 050567 describes POLYTRIM, which is a drug marketed by Allergan and is included in one NDA. It is available from three suppliers. Additional details are available on the POLYTRIM profile page.
The generic ingredient in POLYTRIM is polymyxin b sulfate; trimethoprim sulfate. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.
The generic ingredient in POLYTRIM is polymyxin b sulfate; trimethoprim sulfate. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.
Summary for 050567
| Tradename: | POLYTRIM |
| Applicant: | Allergan |
| Ingredient: | polymyxin b sulfate; trimethoprim sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050567
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POLYTRIM | polymyxin b sulfate; trimethoprim sulfate | SOLUTION/DROPS;OPHTHALMIC | 050567 | NDA AUTHORIZED GENERIC | Pacific Pharma, Inc. | 60758-908 | 60758-908-10 | 1 BOTTLE, DROPPER in 1 CARTON (60758-908-10) / 10 mL in 1 BOTTLE, DROPPER |
| POLYTRIM | polymyxin b sulfate; trimethoprim sulfate | SOLUTION/DROPS;OPHTHALMIC | 050567 | NDA AUTHORIZED GENERIC | DIRECT RX | 61919-233 | 61919-233-10 | 10 mL in 1 CARTON (61919-233-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 10,000 UNITS/ML;EQ 1MG BASE/ML | ||||
| Approval Date: | Oct 20, 1988 | TE: | RLD: | Yes | |||||
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