Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208206
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | 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 |
---|---|---|---|---|---|---|---|
04/08/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/11/2022 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
08/23/2019 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
RALOXIFENE HYDROCHLORIDE
TABLET;ORAL; 60MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EVISTA | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | Yes | AB | 020815 | LILLY |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 208206 | AMNEAL PHARMS |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 204310 | AUROBINDO PHARMA |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 211324 | CADILA PHARMS LTD |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 204491 | GLENMARK PHARMS LTD |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 090842 | INVAGEN PHARMS |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 206384 | SCIEGEN PHARMS INC |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 078193 | TEVA PHARMS USA |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 200825 | WATSON LABS INC |