Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 090879
Company: ORCHID HLTHCARE
Company: ORCHID HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 1.5MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 3MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 4.5MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 6MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 06/10/2015 | ORIG-1 | Approval |
Label is not available on this site. |
RIVASTIGMINE TARTRATE
CAPSULE;ORAL; EQ 1.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EXELON | RIVASTIGMINE TARTRATE | EQ 1.5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 020823 | NOVARTIS |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 1.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 091689 | ALEMBIC PHARMS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 1.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 091072 | APOTEX INC |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 1.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204572 | AUROBINDO PHARMA LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 1.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203844 | CADILA PHARMS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 1.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207797 | CHARTWELL RX |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 1.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077130 | DR REDDYS LABS INC |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 1.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203148 | MACLEODS PHARMS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 1.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090879 | ORCHID HLTHCARE |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 1.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077131 | SUN PHARM INDS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 1.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077129 | WATSON LABS |
CAPSULE;ORAL; EQ 3MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EXELON | RIVASTIGMINE TARTRATE | EQ 3MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 020823 | NOVARTIS |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 3MG BASE | CAPSULE;ORAL | Prescription | No | AB | 091689 | ALEMBIC PHARMS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 3MG BASE | CAPSULE;ORAL | Prescription | No | AB | 091072 | APOTEX INC |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 3MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204572 | AUROBINDO PHARMA LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 3MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203844 | CADILA PHARMS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 3MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207797 | CHARTWELL RX |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 3MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077130 | DR REDDYS LABS INC |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 3MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203148 | MACLEODS PHARMS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 3MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090879 | ORCHID HLTHCARE |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 3MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077131 | SUN PHARM INDS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 3MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077129 | WATSON LABS |
CAPSULE;ORAL; EQ 4.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EXELON | RIVASTIGMINE TARTRATE | EQ 4.5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 020823 | NOVARTIS |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 4.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 091689 | ALEMBIC PHARMS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 4.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 091072 | APOTEX INC |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 4.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204572 | AUROBINDO PHARMA LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 4.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203844 | CADILA PHARMS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 4.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207797 | CHARTWELL RX |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 4.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077130 | DR REDDYS LABS INC |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 4.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203148 | MACLEODS PHARMS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 4.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090879 | ORCHID HLTHCARE |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 4.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077131 | SUN PHARM INDS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 4.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077129 | WATSON LABS |
CAPSULE;ORAL; EQ 6MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EXELON | RIVASTIGMINE TARTRATE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 020823 | NOVARTIS |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 091689 | ALEMBIC PHARMS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 091072 | APOTEX INC |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204572 | AUROBINDO PHARMA LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203844 | CADILA PHARMS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207797 | CHARTWELL RX |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077130 | DR REDDYS LABS INC |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203148 | MACLEODS PHARMS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090879 | ORCHID HLTHCARE |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077131 | SUN PHARM INDS LTD |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077129 | WATSON LABS |
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