Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088108
Company: ROXANE
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/08/1983 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/05/2020 SUPPL-21 REMS-Proposal

Label is not available on this site.

04/01/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/01/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/25/1995 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/19/1995 SUPPL-14 Labeling

Label is not available on this site.

04/01/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/01/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/12/1992 SUPPL-11 Labeling

Label is not available on this site.

02/06/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/31/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/31/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/26/1990 SUPPL-7 Labeling

Label is not available on this site.

07/01/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/01/1988 SUPPL-4 Manufacturing (CMC)

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
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 090065 EPIC PHARMA LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 210484 NOSTRUM LABS INC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 088108 ROXANE
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
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 090635 THEPHARMANETWORK LLC

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