Drugs@FDA: FDA-Approved Drugs
Company: BAUSCH AND LOMB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PENTOLAIR | CYCLOPENTOLATE HYDROCHLORIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
04/29/1994 | 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 |
---|---|---|---|---|---|
02/12/2021 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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11/27/2001 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/07/2001 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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10/05/2000 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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06/27/2000 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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05/15/2000 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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04/28/2000 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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05/18/2000 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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06/07/1999 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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11/19/1998 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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02/10/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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05/28/1996 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/20/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
PENTOLAIR
SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AKPENTOLATE | CYCLOPENTOLATE HYDROCHLORIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040164 | RISING PHARMA |
CYCLOGYL | CYCLOPENTOLATE HYDROCHLORIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 084110 | ALCON LABS INC |
PENTOLAIR | CYCLOPENTOLATE HYDROCHLORIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040075 | BAUSCH AND LOMB |