Application 021974
- Type
- NDA
- Sponsor
- CIPLA LIMITED
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LAMIVUDINE; STAVUDINE | LAMIVUDINE; STAVUDINE | TABLET; ORAL | 150MG; 30MG | No | No |
| 002 | LAMIVUDINE; STAVUDINE | LAMIVUDINE; STAVUDINE | TABLET; ORAL | 150MG; 40MG | 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.
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 1 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16110-367 | Aczone | dapsone | Almirall, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 28939 | ORIG | 2007-01-25 |