Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LANORINAL | ASPIRIN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | CAPSULE;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
12/28/1981 | 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 |
---|---|---|---|---|---|
08/29/2007 | SUPPL-27 | Labeling |
Label is not available on this site. |
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03/01/2007 | SUPPL-25 | Labeling |
Label is not available on this site. |
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12/09/2002 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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08/10/2000 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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01/12/2000 | SUPPL-17 | Labeling |
Label is not available on this site. |
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11/13/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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04/17/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
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04/01/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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04/01/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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09/01/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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09/06/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
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09/04/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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11/17/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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11/17/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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08/25/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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09/10/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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09/10/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
LANORINAL
CAPSULE;ORAL; 325MG;50MG;40MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUTALBITAL, ASPIRIN AND CAFFEINE | ASPIRIN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 078149 | NOSTRUM LABS INC |
LANORINAL | ASPIRIN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 086996 | SANDOZ |