Details for New Drug Application (NDA): 016199
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NDA 016199 describes CORTENEMA, which is a drug marketed by Ani Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the CORTENEMA profile page.
The generic ingredient in CORTENEMA 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.
The generic ingredient in CORTENEMA 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 016199
| Tradename: | CORTENEMA |
| Applicant: | Ani Pharms |
| Ingredient: | hydrocortisone |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 016199
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 016199
Suppliers and Packaging for NDA: 016199
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CORTENEMA | hydrocortisone | ENEMA;RECTAL | 016199 | NDA | ANI Pharmaceuticals, Inc. | 62559-111 | 62559-111-07 | 7 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-07) / 60 mL in 1 BOTTLE, UNIT-DOSE |
| CORTENEMA | hydrocortisone | ENEMA;RECTAL | 016199 | NDA | ANI Pharmaceuticals, Inc. | 62559-111 | 62559-111-11 | 1 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-11) / 60 mL in 1 BOTTLE, UNIT-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | ENEMA;RECTAL | Strength | 100MG/60ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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