Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208324
Company: ALEMBIC PHARMS LTD
Company: ALEMBIC PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;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 |
|---|---|---|---|---|---|---|---|
| 11/16/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208324Orig1s000ltr.pdf |
VARDENAFIL HYDROCHLORIDE
TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| STAXYN | VARDENAFIL HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 200179 | BAYER HLTHCARE |
| VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 208324 | ALEMBIC PHARMS LTD |
| VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 205988 | MACLEODS PHARMS LTD |
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