Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018866
Company: FOUGERA PHARMS INC
Company: FOUGERA PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BETAMETHASONE VALERATE | BETAMETHASONE VALERATE | EQ 0.1% BASE | LOTION;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
08/31/1983 | 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 |
---|---|---|---|---|---|
03/24/2014 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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12/12/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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04/14/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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11/29/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
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10/26/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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10/26/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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05/28/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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05/28/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
BETAMETHASONE VALERATE
LOTION;TOPICAL; EQ 0.1% BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BETAMETHASONE VALERATE | BETAMETHASONE VALERATE | EQ 0.1% BASE | LOTION;TOPICAL | Prescription | Yes | AB | 018866 | FOUGERA PHARMS INC |
BETAMETHASONE VALERATE | BETAMETHASONE VALERATE | EQ 0.1% BASE | LOTION;TOPICAL | Prescription | No | AB | 070052 | KANCHAN HLTHCARE |