Application 212467
- Type
- ANDA
- Sponsor
- Suven Life Sciences Limited
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GLYCOPYRROLATE | GLYCOPYRROLATE | SOLUTION;ORAL | 1MG/5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51672-5316 | Glycopyrrolate Oral Solution | Glycopyrrolate Oral Solution | Taro Pharmaceuticals U.S.A. Inc. | ANDA | Current |
| 68022-0156 | Glycopyrrolate Oral Solution | Glycopyrrolate Oral Solution | Suven Pharmaceuticals Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 65867 | ORIG | 2021-01-07 |