Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
03/25/1998 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74909ap.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/31/2019 | SUPPL-25 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
11/29/2012 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
10/31/2014 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/28/2008 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
12/09/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/18/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/18/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/19/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/19/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
10/10/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/16/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
02/01/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/15/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/06/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
ALPRAZOLAM
TABLET;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074342 | ACTAVIS ELIZABETH |
ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 077741 | APOTEX INC |
ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 203346 | AUROBINDO PHARMA |
ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 207507 | CHARTWELL RX |
ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 200739 | NATCO |
ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074174 | NOVITIUM PHARMA |
ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074909 | SANDOZ |
ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 090248 | STRIDES PHARMA |
ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 090082 | SUN PHARM |
XANAX | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | Yes | AB | 018276 | UPJOHN |