Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085128
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADIPEX-P PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;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
10/22/1980 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-71 Labeling-Package Insert

Label is not available on this site.

01/07/2013 SUPPL-67 Labeling-Package Insert

Label is not available on this site.

04/16/2012 SUPPL-65 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf
10/15/2002 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

09/05/2000 SUPPL-60 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/05/2000 SUPPL-59 Labeling

Label is not available on this site.

09/05/2000 SUPPL-58 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/07/2000 SUPPL-57 Manufacturing (CMC)-Facility

Label is not available on this site.

11/12/1998 SUPPL-56 Labeling

Label is not available on this site.

03/09/1998 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

12/16/1997 SUPPL-54 Labeling

Label is not available on this site.

05/29/1997 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

11/26/1996 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

12/13/1996 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

05/29/1997 SUPPL-49 Labeling

Label is not available on this site.

05/29/1997 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

05/29/1997 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

05/29/1997 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

02/13/1996 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

03/02/1995 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

11/16/1995 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/01/1994 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/01/1994 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/01/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/04/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/22/1993 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/30/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/09/1990 SUPPL-13 Labeling

Label is not available on this site.

12/23/1988 SUPPL-12 Labeling

Label is not available on this site.

07/30/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/08/1984 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/08/1984 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/08/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/23/1983 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/14/1983 SUPPL-4 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-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf

ADIPEX-P

TABLET;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 TABLET;ORAL Prescription No AA 085128 TEVA
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 203068 AUROLIFE PHARMA LLC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 090470 BARR
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 200272 ELITE LABS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 040190 ELITE LABS INC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 091451 INGENUS PHARMS NJ
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 202942 INVAGEN PHARMS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 205008 KEN LIFESCIENCE
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 040876 KVK TECH
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 040555 LANNETT
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 206342 POLYGEN PHARMS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 040377 PRINSTON INC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 040790 SUN PHARM INDS INC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 040526 SUN PHARM INDUSTRIES

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