Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080571
Company: DR REDDYS
Company: DR REDDYS
| 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 |
| THIAMINE HYDROCHLORIDE | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE;INJECTION | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 02/26/1974 | 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 |
|---|---|---|---|---|---|
| 02/19/1999 | SUPPL-144 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-142 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-141 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 11/14/1994 | SUPPL-140 | Labeling |
Label is not available on this site. |
||
| 12/14/1992 | SUPPL-139 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1992 | SUPPL-137 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1992 | SUPPL-136 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1992 | SUPPL-135 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1988 | SUPPL-133 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1986 | SUPPL-131 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1985 | SUPPL-130 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1985 | SUPPL-129 | 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 |