Skip to contentApplication 078030
- Type
- ANDA
- Sponsor
- CIPLA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | STAVUDINE | STAVUDINE | FOR SOLUTION;ORAL | 1MG/ML | No | No |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A078030-001 | STAVUDINE | STAVUDINE | 1MG/ML | FOR SOLUTION / ORAL | | | 2009-03-20 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 53104-0111 | stavudine | stavudine | Cipla Ltd. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9109 | ORIG | 2009-03-24 |