Details for New Drug Application (NDA): 050201
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NDA 050201 describes OPHTHOCORT, which is a drug marketed by Parkedale and is included in one NDA. Additional details are available on the OPHTHOCORT profile page.
The generic ingredient in OPHTHOCORT is chloramphenicol; hydrocortisone acetate; polymyxin b sulfate. There are fourteen drug master file entries for this compound. Additional details are available on the chloramphenicol; hydrocortisone acetate; polymyxin b sulfate profile page.
The generic ingredient in OPHTHOCORT is chloramphenicol; hydrocortisone acetate; polymyxin b sulfate. There are fourteen drug master file entries for this compound. Additional details are available on the chloramphenicol; hydrocortisone acetate; polymyxin b sulfate profile page.
Summary for 050201
| Tradename: | OPHTHOCORT |
| Applicant: | Parkedale |
| Ingredient: | chloramphenicol; hydrocortisone acetate; polymyxin b sulfate |
| Patents: | 0 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | OINTMENT;OPHTHALMIC | Strength | 10MG/GM;5MG/GM;10,000 UNITS/GM | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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