Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216859
Company: MANKIND PHARMA
Company: MANKIND PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/29/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216859Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/15/2023 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
PHENYLEPHRINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC; 2.5%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 207926 | ALCON |
PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 215183 | CAPLIN |
PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 216859 | MANKIND PHARMA |
PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 203510 | PARAGON BIOTECK |