Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210901
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | 0.665MG/SPRAY | SPRAY, METERED;NASAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
01/28/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/27/2023 | SUPPL-4 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
OLOPATADINE HYDROCHLORIDE
SPRAY, METERED;NASAL; 0.665MG/SPRAY
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | 0.665MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 210901 | AMNEAL |
OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | 0.665MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 091572 | APOTEX INC |
OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | 0.665MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 202853 | PADAGIS ISRAEL |