BACITRACIN ZINC
BACITRACIN ZINC
STRATUS PHARMACEUTICAL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3002787468 | 3002787468 | STRATUS PHARMACEUTICAL | 1 | N | 2026-01-01 | 12379 SW 130th Street Miami FL US 33186 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 234268 | 1842579431 | K110172 | SONAFINE WOUND DRESSING | FRO | 2011-08-19 |
| 234268 | 1330928555 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FRO | 2 | 2011-08-19 |
NDC#
Double Antibiotic
BACITRACIN ZINC and POLYMYXIN B SULFATE
Stratuscare Glycerin Laxative Pediatric
Glycerin
Stratuscare Adult Glycerin
Glycerin
Stratuscare Bisacodyl
Bisacodyl
Pramoxine Hydrochloride Anorectal
Pramoxine Hydrochloride
ARCTIC RELIEF
MENTHOL, UNSPECIFIED FORM
Azolen
Miconazole Nitrate
AZOLEN
MICONAZOLE NITRATE
LIDOCAINE
LIDOCAINE
Lidocaine
Lidocaine
Lidocaine
Lidocaine
Peviderm Pramoxine Hydrocholride 1%
Pramoxine Hydrochloride
PMN#
SONAFINE WOUND DRESSING
STRATUS PHARMACEUTICAL
GUDID#
Stratus Pharmaceuticals, Inc. - Venelex 5gm/60ct UD dressing, wound, occlusive
2025-11-10
Stratus Pharmaceuticals, Inc. - Venelex 2oz dressing, wound, occlusive
2025-11-10
Stratus Pharmaceuticals, Inc. - Venelex 1oz dressing, wound, occlusive
2025-11-10
Stratus Pharmaceuticals, Inc. - Sonafine dressing, wound, drug Topical Emulsion 90gm. SonaFine is registered as Dressing Wound Drug werein the drug is a preservative. SonaFine is not promoted as an antibacterial or antimicrobial dressing. It is not promoted to treat infected wounds.
2025-11-10
Stratus Pharmaceuticals, Inc. - Sonafine Dressing, wound, drug Topical Emulsion 5gm/20. SonaFine is registered as Dressing Wound Drug werein the drug is a preservative. SonaFine is not promoted as an antibacterial or antimicrobial dressing. It is not promoted to treat infected wounds.
2025-11-10
Stratus Pharmaceuticals, Inc. - Sonafine Dressing, wound, drug Topical Emulsion 45gm. SonaFIne is registered as Dressing Wound Drug werein the drug is a preservative. SonaFine is not promoted as an antibacterial or antimicrobial dressing. It is not promoted to treat infected wounds.
2025-11-10