Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077131
Company: SUN PHARM
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
10/22/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077131s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/16/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

04/16/2019 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/17/2015 SUPPL-4 Labeling-Package Insert

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
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
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
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
RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE;ORAL Prescription No AB 077129 WATSON LABS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English