Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074921
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTAZOLAM | ESTAZOLAM | 1MG | TABLET;ORAL | Prescription | AB | No | No |
ESTAZOLAM | ESTAZOLAM | 2MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
07/10/1997 | 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 |
---|---|---|---|---|---|
01/17/2023 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
02/05/2021 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
02/06/2019 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
12/16/2016 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
02/20/2008 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
01/08/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
11/08/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/07/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
ESTAZOLAM
TABLET;ORAL; 1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTAZOLAM | ESTAZOLAM | 1MG | TABLET;ORAL | Prescription | No | AB | 074921 | DR REDDYS LABS SA |
ESTAZOLAM | ESTAZOLAM | 1MG | TABLET;ORAL | Prescription | No | AB | 074826 | NOVITIUM PHARMA |
ESTAZOLAM | ESTAZOLAM | 1MG | TABLET;ORAL | Prescription | No | AB | 074818 | WATSON LABS |
TABLET;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTAZOLAM | ESTAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074921 | DR REDDYS LABS SA |
ESTAZOLAM | ESTAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074826 | NOVITIUM PHARMA |
ESTAZOLAM | ESTAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074818 | WATSON LABS |