Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040074
Company: BAUSCH AND LOMB
Company: BAUSCH AND LOMB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPARACAINE HYDROCHLORIDE | PROPARACAINE HYDROCHLORIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | 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 |
|---|---|---|---|---|---|---|---|
| 09/29/1995 | 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 |
|---|---|---|---|---|---|
| 11/27/2001 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/07/2001 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/05/2000 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/27/2000 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/15/2000 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/18/2000 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/07/1999 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 11/19/1998 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 07/23/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |
PROPARACAINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALCAINE | PROPARACAINE HYDROCHLORIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 080027 | ALCON LABS INC |
| PROPARACAINE HYDROCHLORIDE | PROPARACAINE HYDROCHLORIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040074 | BAUSCH AND LOMB |
| PROPARACAINE HYDROCHLORIDE | PROPARACAINE HYDROCHLORIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040277 | RISING |