اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ADIPEX-P از شرکت TEVA
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 |
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 | 040887 | KVK TECH |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | CAPSULE;ORAL | Prescription | No | AA | 201961 | LANNETT CO INC |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | CAPSULE;ORAL | Prescription | No | AA | 205017 | NUVO PHARM |
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