Application 217069
- Type
- ANDA
- Sponsor
- MANKIND PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 10MG/ML (10MG/ML) | No | No |
| 002 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 50MG/5ML (10MG/ML) | No | No |
| 003 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 100MG/10ML (10MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70756-621 | Phenylephrine hydrochloride | phenylephrine hydrochloride | Lifestar Pharma LLC | ANDA | Current |
| 70756-622 | Phenylephrine hydrochloride | phenylephrine hydrochloride | Lifestar Pharma LLC | ANDA | Current |
| 70756-623 | Phenylephrine hydrochloride | phenylephrine hydrochloride | Lifestar Pharma LLC | ANDA | Current |