Application 210911
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | CAPSULE, EXTENDED RELEASE | 36.25MG | No | No |
| 003 | CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | CAPSULE, EXTENDED RELEASE | 145MG | No | No |
| 004 | CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | CAPSULE, EXTENDED RELEASE | 23.75MG | No | No |
| 005 | CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | CAPSULE, EXTENDED RELEASE | 95MG | No | No |
| 006 | CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | CAPSULE, EXTENDED RELEASE | 245MG | No | No |
| 007 | CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | CAPSULE, EXTENDED RELEASE | 61.25MG | No | No |
| 008 | CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | CAPSULE, EXTENDED RELEASE | 48.75MG | No | No |
| 009 | CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | CAPSULE, EXTENDED RELEASE | 195MG | 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 |
|---|
| 64369 | ORIG | 2020-08-21 |