Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084285
Company: LANNETT
Company: LANNETT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 09/30/1974 | 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 |
|---|---|---|---|---|---|
| 04/30/2013 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/30/2011 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/29/2008 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/29/2008 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/07/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/10/2000 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/07/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/03/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/17/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/15/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
DICYCLOMINE HYDROCHLORIDE
CAPSULE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 040319 | AUROBINDO PHARMA USA |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 216639 | COREPHARMA |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 084285 | LANNETT |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 217531 | PRINSTON INC |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 217054 | TWI PHARMS |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 085082 | WATSON LABS |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 040204 | WEST WARD |