Application 206843
- Type
- NDA
- Sponsor
- BRISTOL-MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DAKLINZA | DACLATASVIR DIHYDROCHLORIDE | TABLET;ORAL | EQ 30MG BASE | Yes | No |
| 002 | DAKLINZA | DACLATASVIR DIHYDROCHLORIDE | TABLET;ORAL | EQ 60MG BASE | Yes | No |
| 003 | DAKLINZA | DACLATASVIR DIHYDROCHLORIDE | TABLET;ORAL | EQ 90MG BASE | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0003-0011 | DAKLINZA | daclatasvir | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-0011 | DAKLINZA | daclatasvir | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-0213 | DAKLINZA | daclatasvir | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-0213 | DAKLINZA | daclatasvir | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-0213 | DAKLINZA | daclatasvir | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-0215 | DAKLINZA | daclatasvir | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-0215 | DAKLINZA | daclatasvir | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-0215 | DAKLINZA | daclatasvir | E.R. Squibb & Sons, L.L.C. | NDA | Current |