Details for New Drug Application (NDA): 083011
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NDA 083011 describes PROCTOCORT, which is a drug marketed by Monarch Pharms and is included in one NDA. Additional details are available on the PROCTOCORT profile page.
The generic ingredient in PROCTOCORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
The generic ingredient in PROCTOCORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
Summary for 083011
| Tradename: | PROCTOCORT |
| Applicant: | Monarch Pharms |
| Ingredient: | hydrocortisone |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 083011
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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