Application 216859
- Type
- ANDA
- Sponsor
- MANKIND PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 2.5% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70756-629 | Phenylephrine Hydrochloride | Phenylephrine Hydrochloride | Lifestar Pharma LLC | ANDA | Current |
| 70756-629 | Phenylephrine Hydrochloride | Phenylephrine Hydrochloride | Lifestar Pharma LLC | ANDA | Current |
| 70756-629 | Phenylephrine Hydrochloride | Phenylephrine Hydrochloride Ophthalmic Solution | Lifestar Pharma LLC | ANDA | Current |
| 70756-629 | Phenylephrine Hydrochloride | Phenylephrine Hydrochloride | Lifestar Pharma LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72743 | ORIG | 2022-11-28 |