Details for New Drug Application (NDA): 075172
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The generic ingredient in COLOCORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
Summary for 075172
Tradename: | COLOCORT |
Applicant: | Chartwell |
Ingredient: | hydrocortisone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075172
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 075172
Suppliers and Packaging for NDA: 075172
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLOCORT | hydrocortisone | ENEMA;RECTAL | 075172 | ANDA | Chartwell RX LLC | 62135-020 | 62135-020-07 | 7 BOTTLE in 1 CARTON (62135-020-07) / 60 mL in 1 BOTTLE |
COLOCORT | hydrocortisone | ENEMA;RECTAL | 075172 | ANDA | Chartwell RX LLC | 62135-020 | 62135-020-21 | 3 CARTON in 1 BOX (62135-020-21) / 7 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | ENEMA;RECTAL | Strength | 100MG/60ML | ||||
Approval Date: | Dec 3, 1999 | TE: | AB | RLD: | No |
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