Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040317
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | AB | No | 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 |
|---|---|---|---|---|---|---|---|
| 09/07/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40317ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/30/2013 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/28/2012 | SUPPL-10 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/30/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/12/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/22/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
DICYCLOMINE HYDROCHLORIDE
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 217566 | ANNORA PHARMA |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 040317 | AUROBINDO PHARMA USA |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 217916 | BIONPHARMA |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 216760 | COREPHARMA |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 040161 | HIKMA PHARMS |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 040230 | LANNETT |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 218310 | PRINSTON INC |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 218952 | RISING |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 216736 | RUBICON RESEARCH |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 216782 | TWI PHARMS |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 085223 | WATSON LABS |