Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088023
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADIPEX-P PHENTERMINE HYDROCHLORIDE 37.5MG 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
08/02/1983 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
05/31/2017 SUPPL-43 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/07/2013 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

04/16/2012 SUPPL-37 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/088023s037lbl.pdf
10/15/2002 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/07/2000 SUPPL-32 Manufacturing (CMC)-Facility

Label is not available on this site.

11/12/1998 SUPPL-31 Labeling

Label is not available on this site.

03/09/1998 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/16/1997 SUPPL-29 Labeling

Label is not available on this site.

08/29/1997 SUPPL-28 Labeling

Label is not available on this site.

08/29/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/29/1997 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/29/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/13/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/02/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/23/1988 SUPPL-9 Labeling

Label is not available on this site.

11/12/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/12/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/12/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/12/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/30/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/22/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/16/2012 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/088023s037lbl.pdf

ADIPEX-P

CAPSULE;ORAL; 37.5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADIPEX-P PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE;ORAL Prescription No AA 088023 TEVA
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE;ORAL Prescription No AA 040228 ELITE LABS INC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE;ORAL Prescription No AA 202846 INVAGEN PHARMS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE;ORAL Prescription No AA 205017 KEN LIFESCIENCE
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE;ORAL Prescription No AA 040887 KVK TECH
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE;ORAL Prescription No AA 201961 LANNETT HOLDINGS INC

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