Application 210333
- Type
- ANDA
- Sponsor
- MEITHEAL
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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69097-535 | Phenylephrine hydrochloride | Phenylephrine hydrochloride | Cipla USA Inc. | ANDA | Current |
| 69097-614 | Phenylephrine hydrochloride | Phenylephrine hydrochloride | Cipla USA Inc. | ANDA | Current |
| 71288-808 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-808 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-808 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 54155 | ORIG | 2018-05-11 |