Application 211920
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 50MG/5ML (10MG/ML) | No | No |
| 002 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 100MG/10ML (10MG/ML) | No | No |
| 003 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 10MG/ML (10MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68083-338 | phenylephrine hydrochloride | phenylephrine hydrochloride | Gland Pharma Limited | ANDA | Current |
| 68083-338 | phenylephrine hydrochloride | phenylephrine hydrochloride | Gland Pharma Limited | ANDA | Current |
| 68083-339 | phenylephrine hydrochloride | phenylephrine hydrochloride | Gland Pharma Limited | ANDA | Current |
| 68083-339 | phenylephrine hydrochloride | phenylephrine hydrochloride | Gland Pharma Limited | ANDA | Current |
| 68083-465 | Phenylephrine Hydrochloride | Phenylephrine Hydrochloride | Gland Pharma Limited | ANDA | Current |