Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215692
Company: CAPLIN
Company: CAPLIN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THIAMINE HYDROCHLORIDE | THIAMINE HYDROCHLORIDE | 100MG/ML | 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 |
---|---|---|---|---|---|---|---|
03/06/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
THIAMINE HYDROCHLORIDE
INJECTABLE;INJECTION; 100MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
THIAMINE HYDROCHLORIDE | THIAMINE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215692 | CAPLIN |
THIAMINE HYDROCHLORIDE | THIAMINE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 080571 | DR REDDYS |
THIAMINE HYDROCHLORIDE | THIAMINE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208703 | EUGIA PHARMA |
THIAMINE HYDROCHLORIDE | THIAMINE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 080556 | FRESENIUS KABI USA |
THIAMINE HYDROCHLORIDE | THIAMINE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091623 | MYLAN INSTITUTIONAL |
THIAMINE HYDROCHLORIDE | THIAMINE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206106 | SAGENT PHARMS INC |
THIAMINE HYDROCHLORIDE | THIAMINE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 080575 | WEST-WARD PHARMS INT |