Application 213335
- Type
- ANDA
- Sponsor
- SPECGX LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE | TABLET;ORAL | 2.5MG;0.025MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0406-1236 | Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | SpecGx LLC | ANDA | Current |