Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204645
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 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 |
---|---|---|---|---|---|---|---|
01/20/2017 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204645Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/07/2023 | SUPPL-16 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
09/23/2019 | SUPPL-9 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
06/26/2017 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
TAMSULOSIN HYDROCHLORIDE
CAPSULE;ORAL; 0.4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLOMAX | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE;ORAL | Prescription | Yes | AB | 020579 | SANOFI |
TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE;ORAL | Prescription | No | AB | 207405 | ALKEM LABS LTD |
TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE;ORAL | Prescription | No | AB | 202433 | AUROBINDO PHARMA LTD |
TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE;ORAL | Prescription | No | AB | 211885 | CHARTWELL RX |
TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE;ORAL | Prescription | No | AB | 090377 | IMPAX LABS |
TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE;ORAL | Prescription | No | AB | 204645 | MACLEODS PHARMS LTD |
TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE;ORAL | Prescription | No | AB | 078015 | SANDOZ |
TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE;ORAL | Prescription | No | AB | 090931 | SUN PHARM INDS LTD |
TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE;ORAL | Prescription | No | AB | 078801 | SYNTHON PHARMS |
TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE;ORAL | Prescription | No | AB | 077630 | TEVA PHARMS |
TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE;ORAL | Prescription | No | AB | 078938 | WOCKHARDT |
TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE;ORAL | Prescription | No | AB | 078225 | ZYDUS PHARMS USA INC |