Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077132
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription AB No No
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription AB No No
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG 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
10/05/2007 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077132s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077132s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/16/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/05/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

11/16/2015 SUPPL-3 Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/05/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077132s000lbl.pdf

RISEDRONATE SODIUM

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTONEL RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription Yes AB 020835 APIL
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription No AB 200296 AUROBINDO PHARMA LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription No AB 203533 MACLEODS PHARMS LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription No AB 090886 SUN PHARM
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription No AB 077132 TEVA PHARMS USA

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTONEL RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription Yes AB 020835 APIL
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 200296 AUROBINDO PHARMA LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 203533 MACLEODS PHARMS LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 205280 ORCHID HLTHCARE
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 090886 SUN PHARM
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 077132 TEVA PHARMS USA

TABLET;ORAL; 35MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTONEL RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription Yes AB 020835 APIL
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 090877 APOTEX INC
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 200296 AUROBINDO PHARMA LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 207516 HANGZHOU BINJIANG
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 203533 MACLEODS PHARMS LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 205280 ORCHID HLTHCARE
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 090886 SUN PHARM
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 077132 TEVA PHARMS USA

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