Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086945
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/20/1983 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/86945ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/31/2017 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

12/06/2012 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

12/06/2012 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

11/13/2002 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/11/2001 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

02/02/2000 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

09/24/1998 SUPPL-16 Labeling

Label is not available on this site.

08/10/1998 SUPPL-15 Labeling

Label is not available on this site.

04/30/1998 SUPPL-14 Labeling

Label is not available on this site.

04/12/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/16/1997 SUPPL-12 Labeling

Label is not available on this site.

01/22/1993 SUPPL-11 Labeling

Label is not available on this site.

10/27/1992 SUPPL-10 Labeling

Label is not available on this site.

01/16/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/19/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/26/1989 SUPPL-7 Labeling

Label is not available on this site.

04/12/1988 SUPPL-6 Labeling

Label is not available on this site.

06/12/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/30/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

PHENTERMINE HYDROCHLORIDE

CAPSULE;ORAL; 30MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 204318 AUROLIFE PHARMA LLC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 090591 BARR
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 202248 ELITE LABS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 202858 INVAGEN PHARMS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 204414 INVAGEN PHARMS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 040875 KVK TECH
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 040886 KVK TECH
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 087022 LANNETT
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 091359 LANNETT CO INC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 205019 NUVO PHARM
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 086945 SANDOZ
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 087190 SANDOZ
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 040525 SUN PHARM INDUSTRIES

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