Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | AB | No | No |
MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | AB | No | No |
MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
01/24/2003 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76119tapd.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076119.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/24/2020 | SUPPL-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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02/24/2020 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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02/24/2020 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
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10/24/2014 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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01/31/2013 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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01/31/2013 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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07/19/2010 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/06/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
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11/06/2007 | SUPPL-13 | Labeling |
Label is not available on this site. |
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07/21/2006 | SUPPL-12 | Labeling |
Label is not available on this site. |
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07/12/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
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12/29/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
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06/19/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
MIRTAZAPINE
TABLET;ORAL; 15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076219 | AIPING PHARM INC |
MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 077666 | APOTEX INC |
MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076921 | AUROBINDO |
MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076122 | MYLAN |
MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 216751 | PRASCO |
MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076541 | SUN PHARM INDS INC |
MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076119 | TEVA |
REMERON | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | Yes | AB | 020415 | ORGANON |
TABLET;ORAL; 30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076219 | AIPING PHARM INC |
MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 077666 | APOTEX INC |
MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076921 | AUROBINDO |
MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076122 | MYLAN |
MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 216751 | PRASCO |
MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076541 | SUN PHARM INDS INC |
MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076119 | TEVA |
REMERON | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | Yes | AB | 020415 | ORGANON |
TABLET;ORAL; 45MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 076219 | AIPING PHARM INC |
MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 077666 | APOTEX INC |
MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 076921 | AUROBINDO |
MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 076122 | MYLAN |
MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 216751 | PRASCO |
MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 076541 | SUN PHARM INDS INC |
MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 076119 | TEVA |