Details for New Drug Application (NDA): 019836
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The generic ingredient in SUPPRELIN is histrelin acetate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the histrelin acetate profile page.
Summary for 019836
| Tradename: | SUPPRELIN |
| Applicant: | Shire |
| Ingredient: | histrelin acetate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.2MG BASE/ML | ||||
| Approval Date: | Dec 24, 1991 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.5MG BASE/ML | ||||
| Approval Date: | Dec 24, 1991 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
| Approval Date: | Dec 24, 1991 | TE: | RLD: | No | |||||
Expired US Patents for NDA 019836
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Shire | SUPPRELIN | histrelin acetate | INJECTABLE;INJECTION | 019836-001 | Dec 24, 1991 | ⤷ Get Started Free | ⤷ Get Started Free |
| Shire | SUPPRELIN | histrelin acetate | INJECTABLE;INJECTION | 019836-003 | Dec 24, 1991 | ⤷ Get Started Free | ⤷ Get Started Free |
| Shire | SUPPRELIN | histrelin acetate | INJECTABLE;INJECTION | 019836-002 | Dec 24, 1991 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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