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Application 206888
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TIROFIBAN HYDROCHLORIDE | TIROFIBAN HYDROCHLORIDE | INJECTABLE; INJECTION | 12.5MG/260ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68083-145 | Tirofiban hydrochloride | Tirofiban | Gland Pharma Limited | ANDA | Current |
| 68083-145 | Tirofiban hydrochloride | Tirofiban | Gland Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 65432 | ORIG | 2020-12-01 |