Application 208895
- Type
- ANDA
- Sponsor
- SANDOZ INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CARBIDOPA; LEVODOPA | CARBIDOPA;LEVODOPA | CAPSULE, EXTENDED RELEASE;ORAL | 23.75MG;95MG | No | No |
| 002 | CARBIDOPA; LEVODOPA | CARBIDOPA;LEVODOPA | CAPSULE, EXTENDED RELEASE;ORAL | 36.25MG;145MG | No | No |
| 003 | CARBIDOPA; LEVODOPA | CARBIDOPA;LEVODOPA | CAPSULE, EXTENDED RELEASE;ORAL | 48.75MG;195MG | No | No |
| 004 | CARBIDOPA; LEVODOPA | CARBIDOPA;LEVODOPA | CAPSULE, EXTENDED RELEASE;ORAL | 61.25MG;245MG | No | No |
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 74107 | ORIG | 2023-04-28 |