Details for New Drug Application (NDA): 081271
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NDA 081271 describes TEXACORT, which is a drug marketed by Mission Pharma and is included in two NDAs. It is available from three suppliers. Additional details are available on the TEXACORT profile page.
The generic ingredient in TEXACORT 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 TEXACORT 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 081271
| Tradename: | TEXACORT |
| Applicant: | Mission Pharma |
| Ingredient: | hydrocortisone |
| Patents: | 0 |
Pharmacology for NDA: 081271
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 081271
Suppliers and Packaging for NDA: 081271
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TEXACORT | hydrocortisone | SOLUTION;TOPICAL | 081271 | ANDA | Mission Pharmacal Company | 0178-0455 | 0178-0455-01 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0178-0455-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR |
| TEXACORT | hydrocortisone | SOLUTION;TOPICAL | 081271 | ANDA | Bio Comp Pharma, Inc. | 44523-156 | 44523-156-01 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (44523-156-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 2.5% | ||||
| Approval Date: | Apr 17, 1992 | TE: | RLD: | No | |||||
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