Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202509
Company: ANCHEN PHARMS
Company: ANCHEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE | 0.5MG;0.4MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
02/26/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202509Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/26/2023 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
10/23/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
CAPSULE;ORAL; 0.5MG;0.4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE | 0.5MG;0.4MG | CAPSULE;ORAL | Prescription | No | AB | 202509 | ANCHEN PHARMS |
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE | 0.5MG;0.4MG | CAPSULE;ORAL | Prescription | No | AB | 207769 | ZYDUS PHARMS |
JALYN | DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE | 0.5MG;0.4MG | CAPSULE;ORAL | Prescription | Yes | AB | 022460 | WOODWARD |