NEO-POLY-DEX is a Ophthalmic Ointment in the Human Prescription Drug category. It is labeled and distributed by Butler Animal Health Supply. The primary component is Neomycin Sulfate; Polymyxin B Sulfate; Dexamethasone.
| Product ID | 11695-1436_ca8900f2-cf16-425c-91f3-c41f8296358f |
| NDC | 11695-1436 |
| Product Type | Human Prescription Drug |
| Proprietary Name | NEO-POLY-DEX |
| Generic Name | Neomycin Sulfate, Polymyxin B Sulfate, And Dexamethasone |
| Dosage Form | Ointment |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 1994-07-25 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA064063 |
| Labeler Name | Butler Animal Health Supply |
| Substance Name | NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE |
| Active Ingredient Strength | 4 mg/g; [USP'U]/g; mg/g |
| Pharm Classes | Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 1994-07-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA064063 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1994-07-25 |
| Inactivation Date | 2019-10-29 |
| Ingredient | Strength |
|---|---|
| NEOMYCIN SULFATE | 3.5 mg/g |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 11695-1403 | NEO-POLY-DEX | Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone |
| 11695-1436 | NEO-POLY-DEX | Neomycin sulfate, Polymyxin B Sulfate, and Dexamethasone |
| 13985-014 | Neomycin and Polymyxin B Sulfates and Dexamethasone | Neomycin sulfate, Polymyxin B Sulfate, and Dexamethasone |
| 13985-744 | Neomycin and Polymyxin B Sulfates and Dexamethasone | Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone |
| 24208-795 | Neomycin and Polymyxin B Sulfates and Dexamethasone | Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone |
| 50090-6181 | Neomycin and Polymyxin B Sulfates and Dexamethasone | Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone |
| 63187-669 | Neomycin and Polymyxin B Sulfates and Dexamethasone | Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone |
| 68071-2428 | Neomycin and Polymyxin B Sulfates and Dexamethasone | Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone |
| 68788-6841 | Neomycin and Polymyxin B Sulfates and Dexamethasone | Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone |
| 57319-307 | NPD | Neomycin sulfate, Polymyxin B Sulfate, and Dexamethasone |