Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018013
Company: SPECGX LLC
Company: SPECGX LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
| PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
| PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 08/01/1977 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/09/2019 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018013s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018013Orig1s064ltr.pdf | |
| 07/28/2014 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf | |
| 07/10/2014 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf | |
| 10/26/2012 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf | |
| 07/13/2007 | SUPPL-58 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018013s58lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf | |
| 01/12/2005 | SUPPL-56 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18012s026,18013s056ltr.pdf | |
| 12/06/2004 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/2001 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/2001 | SUPPL-53 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018013_s053_PAMELOR CAPSULES.pdf |
| 04/27/2000 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1999 | SUPPL-51 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/28/1999 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1995 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1995 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/1994 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/15/1994 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1994 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/06/1993 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 07/23/1993 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/17/1993 | SUPPL-38 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/16/1993 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/16/1993 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1993 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/23/1993 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1992 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1992 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/02/1991 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1993 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 03/13/1991 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 03/26/1990 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1989 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/07/1988 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/16/1990 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/25/1986 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/11/1985 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/27/1985 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/11/1984 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/01/1984 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/02/1982 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/25/1982 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/26/1981 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1981 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/20/1979 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/17/1979 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/14/1979 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1982 | SUPPL-2 | Efficacy |
Label is not available on this site. |
||
| 06/29/1978 | SUPPL-1 | Efficacy |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/09/2019 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018013s064lbl.pdf | |
| 07/28/2014 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s063lbl.pdf | |
| 07/10/2014 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s062lbl.pdf | |
| 10/26/2012 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf | |
| 07/13/2007 | SUPPL-58 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018013s58lbl.pdf | |
| 01/12/2005 | SUPPL-56 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf |
PAMELOR
CAPSULE;ORAL; EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 073556 | DR REDDYS LABS SA |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075520 | TARO |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074132 | TEVA |
| PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 018013 | SPECGX LLC |
CAPSULE;ORAL; EQ 25MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 073556 | DR REDDYS LABS SA |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075520 | TARO |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074132 | TEVA |
| PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 018013 | SPECGX LLC |
CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 073556 | DR REDDYS LABS SA |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075520 | TARO |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074132 | TEVA |
| PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 018013 | SPECGX LLC |
CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 073556 | DR REDDYS LABS SA |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075520 | TARO |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074132 | TEVA |
| PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 018013 | SPECGX LLC |