Application 212612
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLYCOPYRROLATE | GLYCOPYRROLATE | INJECTABLE;INJECTION | 0.2MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-5226 | Glycopyrrolate | Glycopyrrolate | A-S Medication Solutions | ANDA | Current |
| 50090-5227 | Glycopyrrolate | Glycopyrrolate | A-S Medication Solutions | ANDA | Current |
| 68083-376 | Glycopyrrolate | Glycopyrrolate | Gland Pharma Limited | ANDA | Current |
| 68083-376 | Glycopyrrolate | Glycopyrrolate | Gland Pharma Limited | ANDA | Current |
| 68083-377 | Glycopyrrolate | Glycopyrrolate | Gland Pharma Limited | ANDA | Current |
| 68083-377 | Glycopyrrolate | Glycopyrrolate | Gland Pharma Limited | ANDA | Current |
| 68083-378 | Glycopyrrolate | Glycopyrrolate | Gland Pharma Limited | ANDA | Current |
| 68083-378 | Glycopyrrolate | Glycopyrrolate | Gland Pharma Limited | ANDA | Current |
| 68083-379 | Glycopyrrolate | Glycopyrrolate | Gland Pharma Limited | ANDA | Current |
| 68083-379 | Glycopyrrolate | Glycopyrrolate | Gland Pharma Limited | ANDA | Current |
| 70700-165 | Glycopyrrolate | Glycopyrrolate | Xiromed LLC | ANDA | Current |
| 70700-165 | Glycopyrrolate | Glycopyrrolate | Xiromed LLC | ANDA | Current |
| 70700-165 | Glycopyrrolate | Glycopyrrolate | Xiromed LLC | ANDA | Current |
| 70700-166 | Glycopyrrolate | Glycopyrrolate | Xiromed LLC | ANDA | Current |
| 70700-166 | Glycopyrrolate | Glycopyrrolate | Xiromed LLC | ANDA | Current |
| 70700-166 | Glycopyrrolate | Glycopyrrolate | Xiromed LLC | ANDA | Current |
| 70700-167 | Glycopyrrolate | Glycopyrrolate | Xiromed LLC | ANDA | Current |
| 70700-167 | Glycopyrrolate | Glycopyrrolate | Xiromed LLC | ANDA | Current |
| 70700-167 | Glycopyrrolate | Glycopyrrolate | Xiromed LLC | ANDA | Current |
| 70700-168 | Glycopyrrolate | Glycopyrrolate | Xiromed LLC | ANDA | Current |
| 70700-168 | Glycopyrrolate | Glycopyrrolate | Xiromed LLC | ANDA | Current |
| 70700-168 | Glycopyrrolate | Glycopyrrolate | Xiromed LLC | ANDA | Current |
| 70700-902 | Glycopyrrolate | Glycopyrrolate | Xiromed, LLC | ANDA | Current |
| 70700-902 | Glycopyrrolate | Glycopyrrolate | Xiromed, LLC | ANDA | Current |
| 70700-903 | Glycopyrrolate | Glycopyrrolate | Xiromed, LLC | ANDA | Current |
| 70700-903 | Glycopyrrolate | Glycopyrrolate | Xiromed, LLC | ANDA | Current |
| 71872-7224 | Glycopyrrolate | Glycopyrrolate | Medical Purchasing Solutions, LLC | ANDA | Current |
| 71872-7292 | Glycopyrrolate | Glycopyrrolate | Medical Purchasing Solutions, LLC | ANDA | Current |