Application 074988
- Type
- ANDA
- Sponsor
- STEVENS J
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE | ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE | TABLET;ORAL | 385MG;30MG;25MG | No | No |
| 002 | ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE | ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE | TABLET;ORAL | 770MG;60MG;50MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50564-554 | Orphenadrine Citrate Aspirin Caffeine | Orphenadrine Citrate, Aspirin, Caffeine | Jerome Stevens Pharmaceuticals, Inc. | ANDA | Current |
| 50564-555 | Orphenadrine Citrate Aspirin Caffeine | Orphenadrine Citrate, Aspirin, Caffeine | Jerome Stevens Pharmaceuticals, Inc. | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 8481 | ORIG | 1999-04-30 |