Drugs@FDA: FDA-Approved Drugs
Company: WEST-WARD PHARMS INT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/27/1972 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/05/2002 | SUPPL-41 | Labeling |
Label is not available on this site. |
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10/01/1999 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/28/1998 | SUPPL-39 | Labeling |
Label is not available on this site. |
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02/11/1999 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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12/01/1998 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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01/29/1998 | SUPPL-36 | Labeling |
Label is not available on this site. |
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06/08/1999 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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02/17/1993 | SUPPL-34 | Labeling |
Label is not available on this site. |
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10/30/1992 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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11/05/1990 | SUPPL-32 | Labeling |
Label is not available on this site. |
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07/23/1992 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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01/27/1992 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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06/07/1990 | SUPPL-29 | Labeling |
Label is not available on this site. |
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11/23/1988 | SUPPL-28 | Labeling |
Label is not available on this site. |
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11/03/1986 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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04/10/1986 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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02/08/1983 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
DIPHENHYDRAMINE HYDROCHLORIDE
INJECTABLE;INJECTION; 50MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040466 | APP PHARMS |
DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 218448 | GLAND PHARMA LTD |
DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205723 | MICRO LABS |
DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040498 | MYLAN INSTITUTIONAL |
DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 080817 | WEST-WARD PHARMS INT |
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091526 | FRESENIUS KABI USA |