Details for New Drug Application (NDA): 075172
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NDA 075172 describes COLOCORT, which is a drug marketed by Chartwell and is included in one NDA. It is available from two suppliers. Additional details are available on the COLOCORT profile page.
The generic ingredient in COLOCORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
The generic ingredient in COLOCORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-one 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 |
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 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc | 23155-926 | 23155-926-51 | 1 BOTTLE in 1 CARTON (23155-926-51) / 60 mL in 1 BOTTLE |
| COLOCORT | hydrocortisone | ENEMA;RECTAL | 075172 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc | 23155-926 | 23155-926-81 | 7 BOTTLE in 1 CARTON (23155-926-81) / 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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