Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080556
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THIAMINE HYDROCHLORIDE | THIAMINE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | 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 |
---|---|---|---|---|---|---|---|
06/20/1972 | 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 |
---|---|---|---|---|---|
08/15/2006 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
07/14/2005 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
07/30/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/07/1997 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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11/04/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/04/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/30/1996 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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12/04/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
09/29/1983 | SUPPL-16 | 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 |