Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080575
Company: WEST-WARD PHARMS INT
Company: WEST-WARD PHARMS INT
| 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 |
|---|---|---|---|---|---|---|---|
| 06/24/1975 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/28/2020 | SUPPL-19 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/27/2000 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/19/1988 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/03/1986 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1982 | SUPPL-6 | Manufacturing (CMC) |
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 |