Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214172
Company: HQ SPCLT PHARMA
Company: HQ SPCLT PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/02/2022 | 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 |
---|---|---|---|---|---|
06/04/2024 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
ESMOLOL HYDROCHLORIDE
INJECTABLE;INJECTION; 1GM/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BREVIBLOC IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019386 | BAXTER HLTHCARE |
ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 216603 | AMNEAL |
ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 216244 | EUGIA PHARMA |
ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 214172 | HQ SPCLT PHARMA |
ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 206608 | MYLAN LABS LTD |
ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 207107 | SAGENT PHARMS INC |
INJECTABLE;INJECTION; 2GM/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019386 | BAXTER HLTHCARE |
ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 216603 | AMNEAL |
ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 216244 | EUGIA PHARMA |
ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 214172 | HQ SPCLT PHARMA |
ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 206608 | MYLAN LABS LTD |
ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 207107 | SAGENT PHARMS INC |