Details for New Drug Application (NDA): 020145
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NDA 020145 describes NITRO-DUR, which is a drug marketed by Uspharma and is included in one NDA. It is available from two suppliers. Additional details are available on the NITRO-DUR profile page.
The generic ingredient in NITRO-DUR is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
The generic ingredient in NITRO-DUR is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 020145
| Tradename: | NITRO-DUR |
| Applicant: | Uspharma |
| Ingredient: | nitroglycerin |
| Patents: | 0 |
Pharmacology for NDA: 020145
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 020145
Suppliers and Packaging for NDA: 020145
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITRO-DUR | nitroglycerin | FILM, EXTENDED RELEASE;TRANSDERMAL | 020145 | NDA AUTHORIZED GENERIC | Dr. Reddy's Laboratories, Inc. | 43598-893 | 43598-893-30 | 30 POUCH in 1 BOX, UNIT-DOSE (43598-893-30) / 1 PATCH in 1 POUCH |
| NITRO-DUR | nitroglycerin | FILM, EXTENDED RELEASE;TRANSDERMAL | 020145 | NDA AUTHORIZED GENERIC | Dr. Reddy's Laboratories, Inc. | 43598-894 | 43598-894-30 | 30 POUCH in 1 BOX, UNIT-DOSE (43598-894-30) / 1 PATCH in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.1MG/HR | ||||
| Approval Date: | Apr 4, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.2MG/HR | ||||
| Approval Date: | Apr 4, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.3MG/HR | ||||
| Approval Date: | Apr 4, 1995 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020145
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Uspharma | NITRO-DUR | nitroglycerin | FILM, EXTENDED RELEASE;TRANSDERMAL | 020145-001 | Apr 4, 1995 | 5,186,938 | ⤷ Get Started Free |
| Uspharma | NITRO-DUR | nitroglycerin | FILM, EXTENDED RELEASE;TRANSDERMAL | 020145-006 | Apr 4, 1995 | 5,186,938 | ⤷ Get Started Free |
| Uspharma | NITRO-DUR | nitroglycerin | FILM, EXTENDED RELEASE;TRANSDERMAL | 020145-004 | Apr 4, 1995 | 5,186,938 | ⤷ Get Started Free |
| Uspharma | NITRO-DUR | nitroglycerin | FILM, EXTENDED RELEASE;TRANSDERMAL | 020145-005 | Apr 4, 1995 | 5,186,938 | ⤷ Get Started Free |
| Uspharma | NITRO-DUR | nitroglycerin | FILM, EXTENDED RELEASE;TRANSDERMAL | 020145-003 | Apr 4, 1995 | 5,186,938 | ⤷ Get Started Free |
| Uspharma | NITRO-DUR | nitroglycerin | FILM, EXTENDED RELEASE;TRANSDERMAL | 020145-002 | Apr 4, 1995 | 5,186,938 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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