Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207777
Company: GLENMARK SPECLT
Company: GLENMARK SPECLT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
APREPITANT | APREPITANT | 40MG | CAPSULE;ORAL | Prescription | AB | No | No |
APREPITANT | APREPITANT | 80MG | CAPSULE;ORAL | Prescription | AB | No | No |
APREPITANT | APREPITANT | 125MG | 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 |
---|---|---|---|---|---|---|---|
10/12/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
APREPITANT
CAPSULE;ORAL; 40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
APREPITANT | APREPITANT | 40MG | CAPSULE;ORAL | Prescription | No | AB | 207777 | GLENMARK SPECLT |
APREPITANT | APREPITANT | 40MG | CAPSULE;ORAL | Prescription | No | AB | 090999 | SANDOZ |
APREPITANT | APREPITANT | 40MG | CAPSULE;ORAL | Prescription | No | AB | 211835 | TORRENT |
CAPSULE;ORAL; 80MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
APREPITANT | APREPITANT | 80MG | CAPSULE;ORAL | Prescription | No | AB | 207777 | GLENMARK SPECLT |
APREPITANT | APREPITANT | 80MG | CAPSULE;ORAL | Prescription | No | AB | 090999 | SANDOZ |
APREPITANT | APREPITANT | 80MG | CAPSULE;ORAL | Prescription | No | AB | 211835 | TORRENT |
EMEND | APREPITANT | 80MG | CAPSULE;ORAL | Prescription | Yes | AB | 021549 | MERCK |
CAPSULE;ORAL; 125MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
APREPITANT | APREPITANT | 125MG | CAPSULE;ORAL | Prescription | No | AB | 207777 | GLENMARK SPECLT |
APREPITANT | APREPITANT | 125MG | CAPSULE;ORAL | Prescription | No | AB | 090999 | SANDOZ |
APREPITANT | APREPITANT | 125MG | CAPSULE;ORAL | Prescription | No | AB | 211835 | TORRENT |
EMEND | APREPITANT | 125MG | CAPSULE;ORAL | Prescription | Yes | AB | 021549 | MERCK |