Drugs@FDA: FDA-Approved Drugs
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;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 |
---|---|---|---|---|---|---|---|
06/28/1993 | 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 |
---|---|---|---|---|---|
01/18/2012 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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03/22/2006 | SUPPL-12 | Labeling |
Label is not available on this site. |
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08/13/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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07/31/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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02/04/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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02/04/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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09/12/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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12/22/1995 | SUPPL-4 | Labeling |
Label is not available on this site. |
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01/25/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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06/12/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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09/27/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |
AMANTADINE HYDROCHLORIDE
SYRUP;ORAL; 50MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 074170 | AUROBINDO PHARMA USA |
AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 074028 | CHARTWELL RX |
AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 075819 | CMP PHARMA INC |
AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 214178 | ELYSIUM |
AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 074509 | PHARM ASSOC |