Drugs@FDA: FDA-Approved Drugs
Company: MYLAN TECHNOLOGIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.6MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | No | Yes |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | No | Yes |
NITROGLYCERIN | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | No | Yes |
NITROGLYCERIN | NITROGLYCERIN | 0.1MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | 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 |
---|---|---|---|---|---|---|---|
08/30/1996 | 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 |
---|---|---|---|---|---|
07/15/2002 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
03/19/2001 | SUPPL-4 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
10/27/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
12/22/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
07/30/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
NITROGLYCERIN
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.6MG/HR
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.6MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 089886 | HERCON PHARM |
NITROGLYCERIN | NITROGLYCERIN | 0.6MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 074559 | MYLAN TECHNOLOGIES |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.4MG/HR
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 089885 | HERCON PHARM |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 074559 | MYLAN TECHNOLOGIES |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.2MG/HR
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 089884 | HERCON PHARM |
NITROGLYCERIN | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 074559 | MYLAN TECHNOLOGIES |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.1MG/HR
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.1MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 089885 | HERCON PHARM |
NITROGLYCERIN | NITROGLYCERIN | 0.1MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 074559 | MYLAN TECHNOLOGIES |
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