Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208305
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AA No No
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AA 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
03/30/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208305Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-2 REMS - MODIFIED - D-N-A

Label is not available on this site.

METHADONE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOLOPHINE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AA 006134 WEST-WARD PHARMS INT
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 211228 ASCENT PHARMS INC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 203502 AUROLIFE PHARMA LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 210484 ELITE LABS INC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 090065 EPIC PHARMA LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 040517 SPECGX LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 208305 SUN PHARM INDUSTRIES
METHADOSE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 040050 SPECGX LLC

TABLET;ORAL; 10MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOLOPHINE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AA 006134 WEST-WARD PHARMS INT
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 211228 ASCENT PHARMS INC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 203502 AUROLIFE PHARMA LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 210484 ELITE LABS INC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 090065 EPIC PHARMA LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 040517 SPECGX LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 208305 SUN PHARM INDUSTRIES
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 090635 THEPHARMANETWORK LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 040241 VISTAPHARM
METHADOSE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 040050 SPECGX LLC

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