Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018578
Company: DR REDDYS LA
Company: DR REDDYS LA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SSD | SILVER SULFADIAZINE | 1% | CREAM;TOPICAL | Prescription | AB | Yes | Yes |
| SSD AF | SILVER SULFADIAZINE | 1% | CREAM;TOPICAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/25/1982 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/21/2014 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/12/1999 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/11/1995 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 08/03/1990 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/11/1990 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 03/15/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/11/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 12/10/1985 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/16/1984 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/19/1983 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/12/1983 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/29/1985 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
SSD
CREAM;TOPICAL; 1%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SILVADENE | SILVER SULFADIAZINE | 1% | CREAM;TOPICAL | Prescription | Yes | AB | 017381 | KING PHARMS LLC |
| SSD | SILVER SULFADIAZINE | 1% | CREAM;TOPICAL | Prescription | Yes | AB | 018578 | DR REDDYS LA |
| THERMAZENE | SILVER SULFADIAZINE | 1% | CREAM;TOPICAL | Prescription | No | AB | 018810 | THEPHARMANETWORK LLC |
SSD AF
There are no Therapeutic Equivalents.