Application 040547
- Type
- ANDA
- Sponsor
- ECI PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHIMAZOLE | METHIMAZOLE | TABLET;ORAL | 5MG | No | No |
| 002 | METHIMAZOLE | METHIMAZOLE | TABLET;ORAL | 10MG | No | No |
| 003 | METHIMAZOLE | METHIMAZOLE | TABLET; ORAL | 20MG | No | No |
| 004 | METHIMAZOLE | METHIMAZOLE | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51293-820 | Methimazole | Methimazole | ECI Pharmaceuticals, LLC | ANDA | Current |
| 51293-820 | Methimazole | Methimazole | ECI Pharmaceuticals, LLC | ANDA | Current |
| 51293-820 | Methimazole | Methimazole | ECI Pharmaceuticals, LLC | ANDA | Current |
| 51293-820 | Methimazole | Methimazole | ECI Pharmaceuticals, LLC | ANDA | Current |
| 51293-821 | Methimazole | Methimazole | ECI Pharmaceuticals, LLC | ANDA | Current |
| 51293-821 | Methimazole | Methimazole | ECI Pharmaceuticals, LLC | ANDA | Current |
| 51293-821 | Methimazole | Methimazole | ECI Pharmaceuticals, LLC | ANDA | Current |
| 51293-821 | Methimazole | Methimazole | ECI Pharmaceuticals, LLC | ANDA | Current |
| 63629-2026 | Methimazole | Methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-2027 | Methimazole | Methimazole | Bryant Ranch Prepack | ANDA | Current |
| 70934-622 | Methimazole | Methimazole | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |