Drugs@FDA: FDA-Approved Drugs
Company: THEA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BETIMOL | TIMOLOL | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | Yes | Yes |
BETIMOL | TIMOLOL | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | Yes | 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 |
---|---|---|---|---|---|---|---|
03/31/1995 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
---|---|---|---|---|---|
10/21/2004 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20439s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20439s011ltr.pdf | |
02/08/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/19/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/30/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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04/05/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
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03/08/1999 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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09/04/1998 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/03/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
01/31/1997 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/21/2004 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20439s011lbl.pdf |
BETIMOL
SOLUTION/DROPS;OPHTHALMIC; EQ 0.25% BASE
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BETIMOL | TIMOLOL | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 020439 | THEA PHARMA |
SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BETIMOL | TIMOLOL | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 020439 | THEA PHARMA |